FDA Accepts Teva Pharma’s BLA for Migraine Drug

After running through what was a volatile past week, Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) seems to be settling down — at least a little. The Israeli pharma giant kicked off the week by announcing that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for fremanezumab in the treatment of migraines. Additionally, the FDA has granted fast track designation for fremanezumab for the prevention of cluster headache.

At the same time, Teva acquired a priority review voucher to expedite the review of fremanezumab, which, if approved, would be a new preventive option for patients suffering from this disease. Currently, regulatory action is expected by mid-2018.

Fremanezumab is also being investigated for the prevention of chronic and episodic cluster headache as part of the Phase 3 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.

Additionally, Teva also has recently initiated a fremanezumab Phase 2 clinical program for the treatment of post-traumatic headache disorder.

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Dr. Marcelo Bigal, M.D., Ph.D., chief scientific officer and head of Specialty R&D at Teva, commented:

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. 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.

Shares of Teva closed Friday at $18.61, with a consensus analyst price target of $17.30 and a 52-week trading range of $10.85 to $38.31. Following the announcement, the stock was initially down about 1% at $18.42 early Monday.

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