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A selection of injector pens for the Wegovy weight loss drug are shown in this photo illustration in Chicago, Illinois, U.S., March 31, 2023. The study called SELECT involved 17,500 patients aged 45 years or older with no prior history of diabetes and started almost five years ago testing if the weekly injection has medical benefits. The landmark trial data shows Wegovy has "the potential to change how obesity is regarded and treated," said Martin Holst Lange, executive vice president for development at Novo Nordisk, in a statement. Novo Nordisk said it expects to file for regulatory approvals of a label indication expansion for the weekly injection in the United States and European Union this year. The detailed results from the trial will be presented at a scientific conference later in 2023.

Persons: Jim Vondruska, Wegovy, Danish drugmaker, That's, Martin Holst Lange, Soren Lontoft Hansen, Novo, Maggie Fick, Nikolaj Skydsgaard, Josephine Mason, Sharon Singleton, Kirsten Donovan Organizations: REUTERS, COPENHAGEN, Novo Nordisk, Nordisk, European Union, World Health Organization, Barclays, Thomson Locations: Chicago , Illinois, U.S, LONDON, Danish, Europe's, United States, Europe, European, Norway, Denmark, Germany, Norwegian

A selection of injector pens for the Wegovy weight loss drug are shown in this photo illustration in Chicago, Illinois, U.S., March 31, 2023. The increasingly popular Wegovy has transformed the weight-loss market since its U.S. launch in June 2021, capturing the attention of patients, investors and celebrities worldwide. Novo's news lifted shares in Europe's second-most valuable listed company after LVMH (LVMH.PA) by more than 17% to record highs. Novo said the eagerly-awaited study results, which have not been peer reviewed, showed that patients on Wegovy had a 20% lower incidence of heart attack, stroke or death from heart disease compared to those on a placebo. Lilly's shares rose nearly 15% in early U.S. trading, boosted by its upbeat quarterly results and Novo's trial data.

Persons: Jim Vondruska, Novo, Wegovy, Jeff Levin, Willis, Willis Towers Watson, Martin Holst Lange, Novo's, Eli Lilly, Mounjaro, Soren Lontoft Hansen, Maggie Fick, Nikolaj Skydsgaard, Jacob Gronholt, Ludwig Burger, Patrick Wingrove, Terje Solsvik, Josephine Mason, Sharon Singleton, Kirsten Donovan, Jan Harvey, Alexander Smith Organizations: REUTERS, COPENHAGEN, Novo Nordisk, Willis Towers, U.S, Union, Pfizer Inc, Amgen Inc, World Health Organization, Barclays, Reuters, Pedersen, Thomson Locations: Chicago , Illinois, U.S, LONDON, Europe's, Europe, United States, Novo, Wegovy, Germany, Denmark, Norway, Copenhagen, Frankfurt, New York, Oslo

☆ Novo Nordisk shares slip on EMA drug safety signal
▼ + stars: | 2023-06-22 | by ( ) www.reuters.com time to read: +2 min

reported that the European Medicines Agency (EMA) had raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs. "Novo Nordisk is aware of the signal and the request by EMA and will deliver a thorough assessment of all relevant data to elucidate this topic," Lars Otto Andersen-Lange, media relations director at Novo Nordisk, told Reuters. report referred to a May 8 statement from EMA, which raised a thyroid cancer safety signal for several drugs in the GLP-1 class, including semaglutide. But a "causal association" between semaglutide and thyroid cancer had not been demonstrated in large-scale clinical trials and post-marketing surveillance, he said. EMA's safety signal had also included GLP-1 drugs from competitors Eli Lilly (LLY.N), Astrazeneca (AZN.L) and Sanofi (SASY.PA).

Persons: Lars Otto Andersen, Lange, Andersen, " Andersen, Eli Lilly, Soren Lontoft Hansen, Nikolaj Skydsgaard, Maggie Fick, Alexander Smith Organizations: Novo Nordisk, European Medicines Agency, EMA, Nordisk, Reuters, Astrazeneca, Sanofi, Thomson Locations: COPENHAGEN, Novo, Denmark's Novo, Copenhagen

☆ Novo Nordisk says EMA raised safety signal on drugs, shares fall
▼ + stars: | 2023-06-22 | by ( Nikolaj Skydsgaard | ) www.reuters.com time to read: +3 min

The European Medicines Agency (EMA) raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs. "Novo Nordisk is aware of the signal and the request by EMA and will deliver a thorough assessment of all relevant data to elucidate this topic," Lars Otto Andersen-Lange, media relations director at Novo Nordisk, told Reuters. reported the EMA safety signal. report referred to a May 8 statement from EMA, which raised a thyroid cancer safety signal for several drugs in the GLP-1 class, including semaglutide. EMA's safety signal also included GLP-1 drugs from competitors Eli Lilly (LLY.N), Astrazeneca (AZN.L) and Sanofi (SASY.PA).

Persons: Eli Lilly, Ozempic, Lars Otto Andersen, Lange, Andersen, " Andersen, Soren Lontoft Hansen, semaglutide, Nikolaj Skydsgaard, Maggie Fick, Alexander Smith Organizations: Sanofi, Novo Nordisk, European Medicines Agency, EMA, Nordisk, Reuters, Astrazeneca, FDA, Thomson Locations: Astrazeneca, COPENHAGEN, Denmark's Novo, Copenhagen

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