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Teva Submits BLA to FDA for Migraine Candidate Fremanezumab

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Teva Pharmaceutical Industries LtdTEVA announced the submission of a biologics license application ("BLA") to the FDA seeking approval for its monoclonal antibody candidate, fremanezumab, as a preventive treatment for migraine.

The BLA submission was supported by positive data from two phase III studies under HALO program, which evaluated the candidate in patients with episodic migraine ("EM") and chronic migraine ("CM").

Fremanezumab was subcutaneously administered once a month for two months (quarterly dose regimen), either in high (675mg) or low doses (225 mg, monthly dose regimen) in the study on CM patients. The data demonstrated statistically significant reduction in the number of monthly headache days when treated with fremanezumabcompared to a placebo. The study also met its secondary endpoints and showed significant improvement over placebo.

Data from the study on EM patients showed that patients who were treated with monthly as well as quarterly dosing regimens of fremanezumab experienced clinically and statistically significant improvements in monthly average number of migraine days and 12 pre-specified analyses.

Given the limited treatment options, fremanezumab represents significant commercial potential. According to Teva's press release, more than a billion people suffer from migraine across the world including 38 million in the United States.

We remind investors that the BLA from Amgen, Inc. AMGN and partner Novartis AG NVS for approval of their CGRP receptor, erenumab, for the prevention of migraine was accepted by the FDA in July. Eli Lilly & Company LLY is also planning to file for FDA approval of its investigational migraine drug, galcanezumab, in the second half of the year.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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