TEVA Hopes to Launch New Migraine Drug Immediately After PDUFA Date

The company is hoping for big sales of fremanezumab.

Patients suffering from migraines have a lot to be hopeful about. Just recently, the US Food and Drug Administration approved Aimovig (erenumab-aooe) from Amgen, the first preventive migraine treatment for adults in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide (cGRP), a molecule that is involved in migraine attacks.

Eli Lilly is expecting an FDA decision on its migraine drug galcanezumab during the third quarter of 2018. And Teva Pharmaceutical Industries announced that it hopes to launch its preventive migraine treatment fremanezumab as early as mid-September.

Teva noted in its recent statement that FDA has raised no issues and the prescription drug user fee act (PDUFA) action date is set for September 16, 2018. The company will be prepared to launch the drug immediately after it receives approval and at least no later than the end of the year.

Hafrun Fridriksdottir, Executive Vice President of Global R&D at Teva commented on bringing the drug to market as quickly as possible. "Our primary goal is to bring preventive treatment options to migraine patients as quickly as possible. We are encouraged by the ongoing communications with the FDA as we work to bring this important therapy to patients."


Guy Tiene

Guy supports the success of life science organizations by identifying synergies across research, content, marketing and communications resources to drive value for clients. With over 30 years of education and marketing experience and 18 years in the life sciences alone, Guy leads our editorial standards for client content, Pharma’s Almanac and Nice Insight research-based industry content as well as external communications for clients. Having served as head of global marketing and communications for a CMO, he also brings critical insight and guidance to all communications. Guy holds a Masters degree from Columbia University.