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FDA Confirms September Action Date for Teva's Migraine Drug

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Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) confirmed that FDA has extended the action date of the Biologics License Application (BLA) for fremanezumab. The action date for fremanezumab is now set for September 16, 2018, which was previously set for mid-June. There are no additional data requests from the FDA.

Fremanezumab is an investigational therapy currently under review by the FDA as a quarterly or monthly injection for the preventive treatment of migraine in adults.  It is also under review in the European Union.

Shares of Teva increased 11.6% year to date against the industry’s decline of 6.2%.

We remind investors that the FDA accepted for review the company’s BLA for fremanezumab  in December 2017 and  granted fast-track designation to the candidate. However, in January 2018, Teva’s partner Celltrion received a warning letter from FDA for a facility in South Korea, following an inspection of the fill/finish side of the facility, thus delaying the approval of the drug. This facility manufactures active pharmaceutical ingredients (APIs) for fremanezumab.

Teva, thus, stated in its first quarter 2018 earnings call that it did not expect to receive FDA approval on its BLA for fremanezumab on the mid-June date. The company was in a constructive dialogue with the FDA in close collaboration with partner Celltrion.

Recently, we note that Amgen (AMGN - Free Report) and partner Novartis (NVS - Free Report) have received FDA approval for their pipeline candidate Aimovig (erenumab) for the prevention of migraine. The drug is the first FDA-approved treatment, specifically developed to treat migraine by blocking calcitonin gene-related peptide ("CGRP") receptor.

Another Pharma giant Eli Lilly (LLY - Free Report) has anti-CGRP candidate- galcanezumab, which is under review in the United States. A decision on galcanezumab is expected in the third quarter of the year.

Teva carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here

Teva Pharmaceutical Industries Ltd. Price

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