Novo Nordisk notched another win Friday as its mega blockbuster Wegovy (semaglutide) proved to also help patients with a common type of heart failure. The Danish pharma company announced results from a Phase III trial, published in The New England Journal of Medicine, adding to the drug’s growing list of benefits.
Tag Archive for: semaglutide
The Medicines and Healthcare products Regulatory Agency said AstraZeneca’s GLP-1 drug for type 2 diabetes, called exenatide and marketed as Bydureon, was also included in the review.
The European Medicines Agency (EMA) is probing Novo Nordisk’s diabetes drug Ozempic and weight-loss treatment Saxenda after Iceland’s health regulator flagged three cases of patients on the drugs thinking about suicide or self-harm.
The European Medicines Agency recently flagged a safety signal related to GLP-1 receptor agonists and sent a list of questions to manufacturers including Novo Nordisk, Eli Lilly, Sanofi and AstraZeneca.
Novo Nordisk is the only company with FDA approval to sell semaglutide drugs. It said that the pharmacies are selling new drugs without FDA approval and claiming to compete with Novo Nordisk’s approved drugs, violating federal and state law.
Novo plans to seek U.S. and European regulatory approval of the high-dose pill later this year, but timing of a market launch is “to be determined,” according to Mico Guevarra, medical director at Novo Nordisk.
A thyroid cancer safety signal was raised by the EU’s drugs watchdog last month over several Novo Nordisk (NOVOb.CO) products including semaglutide, which is used in popular diabetes and obesity medicines Ozempic and Wegovy.
Wegovy maker Novo Nordisk on Tuesday said it had sued some medical spas and wellness clinics in the United States for selling products claiming to contain semaglutide, the key ingredient in its popular weight-loss and diabetes drugs.
The company teased data for efinopegdutide, a GLP-1/glucagon receptor co-agonist, in nonalcoholic steatohepatitis compared to Novo Nordisk’s semaglutide, which is not yet approved for NASH.
The FDA has warned that drug compounders are selling products that falsely claim to contain semaglutide, the same active ingredient as Novo Nordisk’s blockbuster diabetes and obesity drugs Ozempic and Wegovy their oral sibling Rybelsus.