Fremanezumab under review in the United States and Europe
Teva Pharmaceutical (TEVA) has a number of key specialty assets that are touted as key long-term growth drivers for the company.
Fremanezumab, a drug used for the treatment of migraines in adults, is one such product in the company’s specialty asset portfolio. The drug was accepted for review by the FDA in December 2017 and by the EMA (European Medicines Agency) in February 2018.
The main API (active pharmaceutical ingredient) supplier for Teva’s Fremanezumab will be Celltrion Healthcare, a South Korea–based drugmaker.
The Celltrion facility received a warning letter from the FDA in February 2018 citing poor practices followed in the fill and finish part of the facility. The letter didn’t mention any issues with the API part of the facility, but market analysts believe that the area may have issues such as those related to data integrity.
Concerns related to Fremanezumab
Teva plans to have two API suppliers for Fremanezumab in the long term, but in the near term, the company is unlikely to switch to another supplier. Meanwhile, Amgen (AMGN), Novartis (NVS), and Eli Lilly (LLY) await FDA approval for their competing drugs for migraine treatment. Alder BioPharmaceuticals is one of the other pharmaceutical companies in the market with a potential migraine candidate in late-stage development.
As per Teva’s CEO, Kåre Schultz, it typically takes 6–18 months for the resolution of a warning letter, but Fremanezumab’s API manufacturing hasn’t been affected by the letter. The company could receive FDA approval soon, but it isn’t sure.