FDA advisory committee recommends once-weekly semaglutide for type 2 diabetes. - Novo Nordisk.
Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA voted 16-0 in favour of the approval of once-weekly semaglutide to improve glycaemic control in adults with type 2 diabetes. One member of the committee abstained. Based on the data included in the New Drug Application (NDA) for semaglutide, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to establish the efficacy and safety profile of semaglutide for the treatment of type 2 diabetes in adults.
The recommendation for approval was based on a global development programme involving more than 8,000 adults with type 2 diabetes in the eight SUSTAIN phase IIIa clinical trials, including a cardiovascular outcomes trial.
Comment: Semaglutide was filed at EMA in December 2016 and the drug is also pending approval in Japan. Novo Nordisk is developing an oral formulation �currently in Phase III study � which could be a competitive advantage if it succeeds.
Related news and insights
Genentech/Roche announced that the FDA has approved Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.
Oncopeptides announced that the company has decided to withdraw Pepaxto (INN melphalan flufenamide) from the market in the US, following the phase III OCEAN study, which showed an overall survival in the ITT population with a HR of 1.104. The decision has been made after interactions and dialogue with the FDA. Pepaxto was granted accelerated approval on February 26th 2021.
Johnson & Johnson announced the FDA has issued Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine; and for eligible individuals who received a different authorized or approved COVID-19 vaccine.