The move follows a review that started in July and covered a range of drugs known as GLP-1 receptor agonists, also including Eli Lilly’s Trulicity, Sanofi’s Suliqua, AstraZeneca’s Bydureon and Novo’s Rybelsus and Saxenda.
The company said that the marketing authorization decision could come early next year.
Mirati Therapeutics said on Friday the European medicines regulator’s panel has recommended approval of its treatment for a type of lung cancer.
The safety panel reviewed data from Novo’s popular diabetes drug Ozempic and weight loss treatment Wegovy, which contain the same active ingredient, semaglutide.
The company stated that the European Union medicines regulator recommended a marketing authorization for the company’s drug Prevymis to treat a type of infection in adult kidney transplant recipients at high risk.
The decision comes after Amylyx in June requested a formal re-examination of the initial negative opinion adopted by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
The European Union medicines regulator recommended a conditional marketing authorization for U.S. drugmaker Pfizer’s therapy for a type of blood cancer that is difficult to treat.
Last November Blenrep failed to meet the main goal in a late-stage study that was designed to show it was better than an existing treatment on the market, leading GSK to stop selling the drug in the United States.
GSK said the EMA’s Committee for Medicinal Products for Human Use’s (CHMP) positive opinion was based on results from studies in which the medicine, given as few as six times per year, demonstrated superior efficacy to a daily oral PrEP option in reducing the risk of HIV.
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.