Teva Pharmaceutical Industries Gets FDA Priority Review for Fremanezumab, Putting It a Month Behind Amgen in Race for Migraine Market
Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) has secured a priority review at the FDA for its fremanezumab’s BLA for prevention of migraine.
Securing a priority review for fremanezumab means Teva will wait six months rather than the typical 10 months to learn whether the FDA will grant it approval. The priority voucher puts Teva’s PDUFA in June 2018, which is ~1 month after Amgen, Inc.’s (NASDAQ:AMGN) erenumab, which has a 5/17/18 PDUFA.
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Fremanezumab is also being investigated for the prevention of chronic and episodic cluster headache as part of the Phase III ENFORCE clinical research program, which has been granted fast track designation by the FDA. Trial participant recruitment is now underway and the studies are expected to conclude in early 2019.
“The progression of these clinical programs for fremanezumab underscores the potential to advance the treatment paradigm for a large portion of the migraine and headache patient community in need,” said Dr. Marcelo Bigal, M.D., Ph.D., Chief Scientific Officer and Head of Specialty R&D at Teva. “These two critical regulatory milestones, along with the initiation of our Phase II clinical program in post-traumatic headache, and our ongoing migraine program in patients who failed up to four classes of prior preventive treatment, reaffirm Teva’s leadership in migraine and headache disorders and highlight our mission to keep severely affected patients at the forefront of everything we do. We look forward to the potential to make fremanezumab commercially available for the prevention of migraine for patients in the U.S. next year.”