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☆ Eli Lilly’s weight loss drug Zepbound shows promise as a sleep apnea treatment in late-stage trials
▼ + stars: | 2024-04-17 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City, U.S., December 11, 2023. Eli Lilly on Wednesday said its highly popular weight loss drug Zepbound showed the potential to treat patients with the most common sleep-related breathing disorder in two late-stage clinical trials. Zepbound was more effective than a placebo at reducing the severity of obstructive sleep apnea, or OSA, in patients with obesity after a year, according to preliminary data from both trials. Eli Lilly previously announced that the FDA granted Zepbound "fast track designation" for patients with moderate-to-severe OSA and obesity. Zepbound has slipped into shortages since receiving approval in the U.S. for weight management in November.

Persons: Eli Lilly’s, Eli Lilly, Zepbound, Dr, Jeff Emmick, Eli Lilly's Organizations: U.S . Food, Drug Administration, FDA, OSA Locations: New York City, U.S

☆ Johnson & Johnson tops quarterly profit estimates as medical device sales jump
▼ + stars: | 2024-04-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

An entry sign to the Johnson & Johnson campus shows their logo in Irvine, California on August 28, 2019. Johnson & Johnson on Tuesday reported first-quarter adjusted earnings that topped Wall Street's expectations as sales in its medical devices business surged. The company reported $21.38 billion in total sales for the first three months of 2024, up more than 2% from the same quarter in 2023. The company now expects sales of $88 billion to $88.4 billion. Separately on Tuesday, J&J said it will increase its quarterly dividend to $1.24 per share, up 4.2% from $1.19 per share.

Persons: Johnson, J Organizations: Johnson, J's, Humana, UnitedHealth, Elevance, LSEG, & $ Locations: Irvine , California

☆ EU probe of weight loss and diabetes drugs like Wegovy, Ozempic finds no link to suicidal thoughts
▼ + stars: | 2024-04-12 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

European Union drug regulators found no evidence that highly popular weight loss and diabetes drugs such as Wegovy and Ozempic are linked to an increased risk of suicidal thoughts and self-injury, the regulator said Friday. The review examined several drugs from Novo Nordisk , including Wegovy and Ozempic. Clinical trials from Novo Nordisk and Eli Lilly have not demonstrated a link between GLP-1s and suicidal thoughts. The probe also included other active ingredients in older weight loss and diabetes drugs, including dulaglutide, exenatide and lixisenatide. Results from another study conducted by the agency also did not support a link between GLP-1 drugs and the risk of suicidal thoughts.

Persons: Eli Lilly, couldn't, Liraglutide Organizations: Novo Nordisk, European Union, European Medicines Agency, U.S . Food, Drug Administration, EMA, Icelandic Medicines Agency Locations: London, Britain, Novo, U.S, GLP, Wegovy, Ozempic

☆ Moderna halts plans to build Kenya vaccine plant as Covid shot demand plunges
▼ + stars: | 2024-04-11 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Moderna on Thursday said it has paused plans to build a vaccine-manufacturing site in Kenya after a steep drop in demand for its Covid vaccines. Moderna's decision aligns with its broader effort to cut costs by resizing its Covid vaccine-manufacturing footprint. Moderna also had plans to start filling doses of its Covid vaccine in the continent as early as 2023. But the company has since determined that demand in Africa "is insufficient to support the viability of the factory planned in Kenya," Moderna said in a statement on Thursday. "This approach will allow Moderna to better align its infrastructure investments with the evolving healthcare needs and vaccine demand in Africa."

Persons: Moderna Organizations: Moderna, Kenyan Locations: Kenya, Africa

☆ Pfizer's RSV vaccine shows potential to protect high-risk adults ages 18-59, widening possible use
▼ + stars: | 2024-04-09 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

A vaccine from Pfizer showed the potential to protect adults ages 18 to 59 who are at increased risk of getting severely sick from respiratory syncytial virus in a late stage clinical trial, the company said Tuesday. The initial data suggests that Pfizer's shot, known as Abrysvo, could help protect a far wider population from RSV. The jab is currently approved in the U.S., Europe, Japan and other countries for adults ages 60 and older and expectant mothers who can pass on protection to their fetuses. Nearly 10% of U.S. adults ages 18 to 49 have a chronic condition that puts them at risk of severe RSV disease, according to Pfizer. GSK's RSV vaccine for adults ages 60 and above booked around £1.2 billion ($1.5 billion) in sales last year.

Persons: Dr, Iona Munjal, Pfizer's Organizations: Pfizer, CNBC, GlaxoSmithKline Locations: U.S, Europe, Japan

But J&J's drug is walking away with a notable edge over its rival. They add more options to a growing arsenal of treatments that have helped improve outcomes for people with multiple myeloma. But the new approvals also give J&J's therapy, which was developed with Legend Biotech, a clear advantage over Bristol Myers's drug. J&J's drug has gradually gained ground over Abecma in the CAR-T market for multiple myeloma, even though it first entered the market a year later. With the new approval on Friday, Jefferies' Shi expects J&J's drug to win the majority of that market share.

Persons: Jonathan Raa, Johnson, Myers's, Bristol Myers, Jefferies, Kelly Shi, Shi, Carvykti, Cantor Fitzgerald, Rick Bienkowski, Kelsey Goodwin, Annika, annikakim.constantino@nbcuni.com Organizations: Nurphoto, Bristol Myers Squibb, Johnson, Food and Drug Administration, FDA, Legend Biotech, Bristol, New York Stock Exchange, NYSE, Reuters, Mount Sinai Hospital, Getty Locations: Bristol, U.S, EU, Japan, Mount Sinai, New York City

☆ Many CVS drug plans will cover over-the-counter birth control pill at no cost
▼ + stars: | 2024-04-04 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

CVS Health on Thursday said its drug plans will cover the first over-the-counter birth control pill in the U.S. at no cost for many health plan sponsors, a decision that could open the door for more people to prevent unintended pregnancies without a prescription. The company's pharmacy benefit manager, CVS Caremark, said the pill will be added to its preventive services oral contraceptives list and will be covered at zero cost for many sponsors. Pharmacy benefit managers, or PBMs, maintain lists of drugs covered by health insurance plans and negotiate drug discounts with manufacturers. It marks the first time that many U.S. residents are able to buy birth control pills over the counter, the same way they would purchase common pills like Tylenol or Advil. The drug could significantly expand availability of contraception, especially for younger women and those in rural and underserved communities who often have trouble getting access to birth control methods.

Persons: Opill, Biden, Wade Organizations: CVS, CVS Caremark, CNBC, Pharmacy, Drug Administration Locations: San Anselmo , California, U.S, Perrigo

☆ Diabetes drug similar to Ozempic helped slow progression of Parkinson's disease in small trial
▼ + stars: | 2024-04-04 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

A highly popular class of drugs for diabetes and obesity is showing early potential to help patients with Parkinson's disease, too. But more research is needed to determine whether newer iterations of GLP-1s from Novo Nordisk and Eli Lilly may also help Parkinson's patients. The trial followed 156 people with early Parkinson's disease for a year. But one group was given an additional daily injection of Sanofi's drug, while the other was given a placebo. But use of Sanofi's drug was associated with an increased risk of gastrointestinal side effects, which are common across all GLP-1s.

Persons: Eli Lilly, Sanofi, drugmaker Organizations: Sanofi, Novo Nordisk, The New England, French Ministry of Health, Prevention, CNBC Locations: Novo, France, The

☆ Health insurer stocks slide as final Medicare Advantage rates disappoint
▼ + stars: | 2024-04-02 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

Shares of U.S. health insurers fell Tuesday after the Biden administration didn't boost payments for private Medicare plans as much as the insurance industry and investors had hoped. Shares of CVS Health fell more than 8% on Tuesday, while UnitedHealth Group 's stock slid nearly 7%. Shares of Elevance Health dropped more than 3% and Centene 's stock fell 6%. Meanwhile, Humana 's stock fell more than 10%. The health-care giant is far more dependent on those private Medicare plans, known as Medicare Advantage, than its rivals.

Persons: Biden, Humana Organizations: Humana Inc, CVS Health, Elevance Health Locations: Louisville , Kentucky, U.S

☆ Walgreens tops quarterly revenue estimates, but narrows profit outlook in 'challenging' economy
▼ + stars: | 2024-03-28 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

A person rides past a Walgreens truck, owned by the Walgreens Boots Alliance, Inc., in Manhattan, New York City, U.S., November 26, 2021. Walgreens on Thursday reported fiscal second-quarter sales that beat Wall Street's expectations, but lowered the high end of its full-year adjusted earnings outlook in part due to a "challenging" retail environment in the U.S. Analysts surveyed by LSEG expect full-year adjusted earnings of $3.24 per share. Walgreens has not provided that guidance since October, when it said it sees $141 billion to $145 billion in sales. aExcluding certain items, including the $5.8 billion non-cash charge related VillageMD, adjusted earnings per share were $1.20 for the quarter.

Persons: Manmohan Mahajan, Tim Wentworth, Mahajan, Wentworth Organizations: Walgreens, Walgreens Boots Alliance, Inc, U.S, LSEG Locations: Manhattan , New York City, U.S

☆ Moderna moves three vaccines into final stage trials as it works to rebound from Covid slump
▼ + stars: | 2024-03-27 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Moderna has more to offer beyond its Covid vaccine. The update brings Moderna a step closer to having multiple products on the market, which it badly needs amid plunging demand for Covid shots worldwide. Moderna will chart its post-Covid future Wednesday during its fifth annual "Vaccines Day," an investor event in Boston focused on the company's vaccine portfolio. That includes its combination vaccine against Covid and the flu and a shot against another common herpes virus called cytomegalovirus, or CMV. It also includes a new and improved version of Moderna's Covid shot.

Persons: norovirus, Barr, Moderna, Blackstone, Stéphane Bancel Organizations: Moderna, Epstein, Covid, Blackstone Life Sciences, Blackstone Group Locations: Boston, U.S

☆ Altimmune says weight loss drug minimized muscle loss in trial results, which may set it apart
▼ + stars: | 2024-03-27 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Some health experts have said that obesity drugs could shrink critical muscle mass, which could raise the risk of injuries and decrease strength. Those results are similar to those often seen with diet and exercise programs for weight loss. "There is a growing appreciation that the quality of weight loss is as important as the quantity of weight loss." For example, Eli Lilly is testing whether combining its weight loss drug with a monoclonal antibody from Versanis Bio might help patients lose weight while preserving muscle mass. The pharmaceutical giant recently acquired Versanis, which is part of a slate of companies targeting the muscle-loss aspect of weight loss.

Persons: Altimmune, Eli Lilly, Scott Harris Organizations: Novo Nordisk, Novo Nordisk's Ozempic Locations: Altimmune's, Novo

☆ Novo Nordisk's $1,000 diabetes drug Ozempic can be made for less than $5 a month, study suggests
▼ + stars: | 2024-03-27 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

The blockbuster diabetes drug Ozempic could be manufactured for less than $5 a month, even as Novo Nordisk charges close to $1,000 per month for the injection in the U.S. before insurance, a study released Wednesday suggests. The study also comes after years of political pressure on Novo Nordisk and other drugmakers to slash high costs of diabetes care, especially insulin. Ozempic can generally be produced for less than various forms of insulin, according to the study published in JAMA Network Open. Novo Nordisk's list price for a monthly package of Ozempic is $935.77 before insurance and other rebates. In a statement on Wednesday, Novo Nordisk declined to provide production costs for Ozempic and its weight loss drug counterpart Wegovy.

Organizations: Nordisk, Yale University, King's College Hospital, Novo Nordisk, JAMA, Ozempic, University of Liverpool Locations: U.S, London

☆ Moderna says new Covid vaccine showed stronger immune response than current shot in study
▼ + stars: | 2024-03-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Moderna on Tuesday said a new version of its Covid vaccine triggered a stronger immune response against the virus than its current shot in a late-stage trial. Moderna's current Covid vaccine, known as Spikevax, is its only commercially available product. The biotech company's new shot could offer a longer shelf life and easier storage than its Covid vaccine. The company will accomplish that by shortening the length of the mRNA strand in the vaccine, Moderna previously told CNBC. The company's shot against respiratory syncytial virus is expected to win Food and Drug Administration approval in May.

Persons: Moderna Organizations: Moderna, Pfizer, CNBC, subvariants, Food, Drug Locations: U.S, Canada, Covid

☆ FDA approves Merck's drug for rare, deadly lung condition
▼ + stars: | 2024-03-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

The Food and Drug Administration on Tuesday approved a drug from Merck designed to treat a progressive and life-threatening lung condition in a win for both the drugmaker and for patients suffering from the rare disease. The condition refers to when the small blood vessels in the lungs narrow. He noted that the drug will be a "paradigm shift" for patients living with PAH. That includes reducing the risk of death or worsening of the condition by 84% compared to an existing drug alone. Those trials include late-stage studies on patients with more advanced PAH disease, and those who are within the first year after diagnosis.

Persons: Chris Schott, Eliav Barr, PAH, Barr, Merck Organizations: Merck, Drug Administration, JPMorgan, CNBC, Acceleron Pharma Locations: Rahway , New Jersey, U.S, Winrevair

☆ Viking Therapeutics stock jumps more than 25% on promising weight loss pill data
▼ + stars: | 2024-03-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Viking Therapeutics shares jumped more than 25% on Tuesday after the company said its experimental weight loss pill showed positive results in a small study and will enter the next stage of development later this year. The study results add to the excitement around the drugmaker's prospects in the budding weight loss drug market. Based on Tuesday's results, Viking plans to start a phase two trial of its weight loss pill later this year. Weight loss for those patients ranged up to 3.6% higher than those who received a placebo. Viking CEO Brian Lian said during a conference call on Tuesday that it's unclear "how durable" the weight loss is.

Persons: Eli Lilly, Viking, Brian Lian Organizations: Viking Therapeutics, Novo Nordisk, Viking

☆ Amgen wants in on the booming weight loss drug market — and it's taking a different approach
▼ + stars: | 2024-03-24 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +9 min

Mario Tama | Getty ImagesAmgen is taking a new approach as it tries to stand out in a crowded field of drugmakers racing to develop the next blockbuster weight loss drug. It's too early to say how competitive Amgen will be in the budding weight loss drug space, which Novo Nordisk and Eli Lilly have so far dominated. Goldman Sachs also projects that between 10 million and 70 million Americans will be taking weight loss drugs by 2028. The sustained weight loss in Amgen's study appears to contrast with results seen in clinical trials on Zepbound and Wegovy. An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City, U.S., December 11, 2023.

Persons: Mario Tama, Eli Lilly, Goldman Sachs, Zepbound, Eli Lilly's, Amgen's MartiTide, Caroline Apovian, Apovian, Joe Buglewicz, MariTide, Holly Lofton, Eli Lilly’s, Brendan McDermid, Reuters Amgen's, William Blair, Matt Phipps, Phipps Organizations: Getty, Novo Nordisk, Pfizer, Viking Therapeutics, Therapeutics, Zealand Pharma, Boehringer, Center, Weight Management, Wellness, Brigham, Women's, Washington Post, NYU Langone Health, Reuters, William Blair & Company, CNBC Locations: Thousand Oaks , California, Oaks , California, Novo, New York City, U.S

☆ Here's how much people are willing to spend on weight loss drugs, according to a new survey
▼ + stars: | 2024-03-23 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

Boxes of Wegovy made by Novo Nordisk are seen at a pharmacy in London, Britain March 8, 2024. Demand for weight loss drugs is booming in the U.S. despite their limited insurance coverage and roughly $1,000 monthly price tags before discounts. The findings on how much patients are willing to spend underscore concerns about equity in access to the breakthrough drugs while insurance coverage is sparse. GLP-1s include Novo Nordisk 's blockbuster weight loss injection Wegovy and diabetes counterpart Ozempic, along with Eli Lilly' s popular weight loss treatment Zepbound and diabetes injection Mounjaro. Both Novo Nordisk and Eli Lilly have savings programs that aim to reduce out-of-pocket costs for weight loss drugs, regardless of whether a patient has commercial insurance coverage.

Persons: Eli Lilly Organizations: Novo Nordisk, ISI Locations: London, Britain, U.S

☆ Medicare can now cover certain weight loss drugs in a big step for patients
▼ + stars: | 2024-03-21 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Medicare can start covering certain weight loss drugs for the first time — as long as they are approved for an added health benefit, the Centers for Medicare and Medicaid Services said Thursday. Medicare prescription drug plans administered by private insurers, known as Part D, currently cannot cover those drugs for weight loss alone. A provision of a 2003 law established that Medicare Part D plans can't cover drugs used for weight loss, but the program does cover obesity screening, behavioral counseling and bariatric surgery. A CMS spokesperson told CNBC last week that Medicaid programs would be required to cover Wegovy specifically for its new cardiovascular use. Around 1 in 5 state Medicaid programs currently cover GLP-1 drugs for weight loss.

Persons: Ozempic, Eli Lilly Organizations: Novo Nordisk, Medicare, Centers, Services, Drug, Food and Drug Administration, CVS, Aetna, International Foundation of Employee, CNBC, FDA Locations: London, Britain, U.S

☆ Weight loss drug Wegovy is now approved for heart health — but that won't mean broad insurance coverage just yet
▼ + stars: | 2024-03-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +12 min

The blockbuster drug — one of a handful of weight loss treatments to skyrocket in popularity over the last year — is now approved in the U.S. for heart health, too. The spokesperson added that state Medicaid programs would be required to cover Wegovy for its new cardiovascular use. But Gremminger said the standard of care for the long-term use of weight loss drugs is "in flux." State employees will no longer have insurance coverage for GLP-1s when used for weight loss at the beginning of next month. Both drugmakers have launched programs to help patients, with or without commercial insurance coverage, afford their weight loss treatments.

Persons: Klesty, John Crable, Wegovy, Jaime Almandoz, Joe Buglewicz, Shawn Gremminger, Hartley, Gremminger, Dale Folwell, We've, Folwell, Phelan M, Eli Lilly, Ceci Connolly, Julie Stich Organizations: Reuters, Novo Nordisk, CNBC, Medicare, Services, FDA, CVS, Aetna, International Foundation of Employee, Drug Administration, University of Texas Southwestern Medical Center, Washington Post, Getty, National Alliance of Healthcare, Taft, Nordisk, Nordisk's Ozempic, GOP, Carolina, Republican Governors Association, AP, Alliance of Community Health, U.S . Health, IFEBP, BMI Locations: U.S, Novo, Dallas, North Carolina, Orlando , Florida

☆ FDA approves Madrigal Pharmaceuticals drug as first treatment for common NASH liver disease
▼ + stars: | 2024-03-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The Food and Drug Administration on Thursday approved the first-ever treatment for a common and potentially deadly form of liver disease that affects millions worldwide. Novo Nordisk and Eli Lilly are testing their respective blockbuster weight loss injections as treatments for the same kind of liver disease, called nonalcoholic steatohepatitis, or NASH. Madrigal's drug, which will be marketed as Rezdiffra, is specifically approved to treat patients with NASH who also have moderate-to-advanced liver scarring. NASH is a serious form of liver disease characterized by excess fat buildup and inflammation in the liver and can lead to liver scarring, also known as fibrosis, along with liver failure and liver cancer. Roughly 6 million to 8 million people in the U.S. have NASH with moderate-to-advanced liver scarring, according to an estimate cited by the FDA.

Persons: Madrigal, Eli Lilly, NASH, Nikolay Nikolov, Rezdiffra Organizations: Madrigal Pharmaceuticals, Drug Administration, Pharmaceuticals, Novo Nordisk, FDA, Immunology Locations: U.S

☆ Eli Lilly taps Amazon Pharmacy to help deliver weight loss drug Zepbound, other medicines to patients
▼ + stars: | 2024-03-13 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Eli Lilly on Wednesday said Amazon Pharmacy will help send certain prescription drugs, including the red-hot weight loss treatment Zepbound, to patients' homes through the drugmaker's new direct-to-consumer program. The website, LillyDirect, connects people with an independent telehealth company that can prescribe certain drugs if they are eligible. LillyDirect plans to expand the medicines it offers and the companies it partners with in the future, Eli Lilly said. Amazon Pharmacy offers free two-day deliveries to patients with an Amazon Prime membership, which will also apply if they use LillyDirect. But he told CNBC that Eli Lilly expects Amazon Pharmacy and Truepill to have similar processing and shipping times.

Persons: Eli Lilly, Eli Lilly's, Frank Cunningham, Cunningham, Truepill, John Love, We're, Lilly Organizations: Amazon Pharmacy, Amazon, CNBC Locations: U.S

☆ Pfizer is betting big on cancer drugs to turn business around after Covid decline – here's what to know
▼ + stars: | 2024-03-10 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +13 min

Now, the company is betting on cancer drugs to help it regain its footing after a rocky year marked by the rapid decline of its Covid business. That $43 billion Seagen acquisition doubled Pfizer's oncology drug pipeline to 60 different experimental programs. Some analysts noted that it might take a few years for some of Pfizer's cancer drugs in mid-stage development to show pivotal clinical trial data and become less risky. Revenue from the blockbuster breast cancer drug Ibrance and prostate cancer treatment Xtandi, which Pfizer shares with Astellas Pharma, has declined over the past year. They are among the most expensive prescription drugs in the U.S. Before the Seagen deal, 94% of Pfizer's cancer products were small-molecule drugs.

Persons: Wall, Seagen, Chris Boshoff, Boshoff, David Ryder, Trung Huynh, Joe Biden's, Chris Schott, Suneet Varma, RemeGe, Merck, Padcev, Guggenheim, Pfizer's, Pfizer hasn't, Dr, Mikael Dolsten, Irfan Khan Organizations: Nurphoto, Getty, Pfizer, Astellas Pharma, Guggenheim, Bloomberg, UBS, Medicare, Drug Administration, FDA, ADC, JPMorgan, Drugs, CNBC, CVS Pharmacy, Los Angeles Times Locations: Covid, Bothell , Washington, U.S, biologics, China, Eagle Rock , California

☆ Novo Nordisk's Wegovy wins FDA approval for cutting heart disease risks, in move that could expand insurance coverage
▼ + stars: | 2024-03-08 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Injection pens of Novo Nordisk's weight-loss drug Wegovy are shown in this photo illustration in Oslo, Norway, Nov. 21, 2023. The approval also demonstrates that weight loss drugs have significant health benefits beyond shedding unwanted pounds and regulating blood sugar. The FDA said Wegovy patients should use Wegovy in addition to a reduced calorie diet and increased physical activity. Novo Nordisk expects to receive a similar Wegovy approval in the EU this year. The study tested Wegovy in roughly 17,500 people with obesity and heart disease but who did not have diabetes.

Persons: John Sharretts, Ozempic, Wegovy, Eli Lilly, Zepbound Organizations: Drug Administration, Novo Nordisk, Diabetes, FDA's Center, Drug, Research, FDA, Nordisk Locations: Oslo, Norway, Danish, U.S

☆ Eli Lilly says FDA delays approval of Alzheimer's drug in surprise move
▼ + stars: | 2024-03-08 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Eli Lilly headquarters in Indianapolis, Indiana, US, on Wednesday, May 3, 2023. Eli Lilly said Friday that the Food and Drug Administration has pushed back its approval decision deadline for the drugmaker's experimental Alzheimer's treatment donanemab in a surprise move. The agency plans to call a last-minute meeting of its outside advisors to further review the treatment's safety and efficacy in a late-stage trial, Eli Lilly said. It's another setback for Eli Lilly, which is racing to compete with Biogen and Eisai. In 2021, the FDA approved an earlier, ill-fated Alzheimer's drug called Aduhelm from Biogen and Eisai, despite a negative recommendation from the agency's advisory panel.

Persons: Eli Lilly, Eli Lilly's, Leqembi, Anne White Organizations: and Drug Administration, FDA Locations: Indianapolis , Indiana, Biogen

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