Novo Nordisk will start selling its hugely popular obesity drug Wegovy in Germany this month, its third European market, but only people who pay from their own pocket or have certain private health insurance plans will be able to get it.
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.
While many employers have been covering weight-loss drugs, Wegovy’s high price and the huge increase in people taking it has them reconsidering when and how to reimburse use of such treatments to prevent a steep spike in health insurance costs, three healthcare industry experts say.
The National Institute for Health and Care Excellence (NICE) in its draft guidance said it asked the company for more data on whether the drug Mounjaro, also known as tirzepatide, resulted in better weight loss than other drugs belonging to the same class of treatments.
New Phase II data, published in the New England Journal of Medicine, showed Lilly’s oral GLP-1 receptor agonist orforglipron induced nearly 15% weight loss in obese and overweight adults.
The company will now focus on its other therapy danuglipron, which Pfizer said last month helped patients lose weight on par with Novo Nordisk’s Ozempic in a mid-stage study that tested it in patients with Type 2 diabetes.
Every country in the world will see rates of diabetes rise in the next 30 years without action, according to a new global study.
Britain will launch a pilot program to explore how new weekly weight-loss shots such as Novo Nordisk’s Wegovy can be given to obese patients outside of limited specialist services even as the drug’s market launch remains unclear.
The FDA nod “represents an important first step that will one day allow our technology to help many people,” Neuralink said in a tweet. It did not elaborate on the aims of the study, saying only that it was not recruiting yet and more details would be available soon.