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Trial data showed that the treatment slows progression of the brain-wasting disease by 27% for patients in the earliest stages of Alzheimer's. The FDA placed its strongest "boxed" safety warning on Leqembi's label, flagging the risk of potentially dangerous brain swelling for Alzheimer's drugs in the same class. Leqembi is an antibody designed to remove sticky deposits of a protein called amyloid beta from the brains of Alzheimer's patients. Biogen and Eisai stock has risen since FDA granted accelerated approval to Alzheimer's drug Leqembi earlier this yearLeqembi's new label explains the need to monitor patients for potentially dangerous brain swelling and bleeding associated with amyloid-lowering antibodies. The first FDA-approved disease-modifying Alzheimer's drug, Aduhelm, was also developed by partners Eisai and Biogen, but Medicare coverage restrictions have severely limited its use.

Persons: Leqembi, drugmakers, Ivan Cheung, Chiquita Brooks, LaSure, Babak Tousi, Tousi, Biogen, Dr, Erik Musiek, Eli Lilly, Co's, Cheung, Joanne Pike, Eisai, Leqembi's, Deena Beasley, Julie Steenhuysen, Bill Berkrot, Matthew Lewis Organizations: U.S . Food, Drug Administration, FDA, Medicare, Medicaid Services, Cleveland Clinic, Washington University, Barnes, Jewish, Alzheimer’s Association, Alzheimer's Association, Thomson Locations: ANGELES, U.S, Los Angeles, Chicago

All six advisers on the panel voted in favor of Leqembi for treatment of the mind-wasting illness. That approval would also make Leqembi the first disease-modifying drug ever to achieve the regulatory milestone. Leqembi won accelerated approval by the FDA in January based on its ability to remove sticky amyloid plaques from the brain. Most U.S. Alzheimer's patients are Medicare-eligible. “We are in full agreement with the FDA Advisory Committee that Leqembi provides clinical benefit and that this benefit outweighs the risks."

Persons: Eisai, Leqembi, Tanya Simuni, Robert Alexander, Joanne Pike, Leroy Leo, Khushi, Julie Steenhuysen, Bill Berkrot Organizations: Food and Drug Administration, Alzheimer's Association, FDA, Northwestern University Feinberg School of Medicine, Banner Alzheimer's Institute, CAA, Medicare, Wall Street, Analysts, Alzheimer's, Thomson Locations: Leqembi, U.S, Bengaluru, Chicago

The Alzheimer's Association and the pharmaceutical industry say the drug companies are not directly involved in the campaign. But the Alzheimer's Association says patients simply don't have the time to spare. The agency did not address the Alzheimer's Association campaign. Association members have met 30 times with staffers for the state's 20 members of Congress, Ryan Schiff, the chapter's public policy manager, said. Spokespeople for all three companies said they do not work with the Association on its campaign to expand Medicare coverage of the drugs.

☆ Medicare rejects Alzheimer's Association request for unrestricted coverage of treatments like Leqembi
▼ + stars: | 2023-02-23 | by ( Spencer Kimball | ) www.cnbc.com time to read: +6 min

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Due to the drug's high price and Medicare's coverage restrictions, seniors are unable to access the treatment. The letter the Alzheimer's Association sent to CMS in December calling for unrestricted coverage was signed by more than 200 researchers and experts. CMS said it would provide broader coverage of Leqembi on the same day should the FDA fully approve the treatment. Medicare adopted the coverage restrictions after controversy over the Alzheimer's antibody treatment Aduhelm, which was also developed by Eisai and Biogen.

☆ Most Alzheimer’s patients would pay up to $26,500 per year for new treatment Leqembi
▼ + stars: | 2023-01-09 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

Few seniors with early Alzheimer's disease will have access to the new treatment Leqembi due to its high cost and very limited coverage by Medicare. "Even with Medicare coverage, beneficiaries would still be responsible for 20% coinsurance, and that's not a trivial amount." An investigation by lawmakers in the House concluded that the FDA approval process for Aduhelm was "rife with irregularities." "It's not going to be widely available even to people who are potentially eligible based on whether or not they have mild cognitive impairment related to Alzheimer's disease," Neuman said. CMS plans to provide broader coverage for Leqembi if the treatment receives full FDA approval under the traditional process, according to an agency statement.

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