Production & Manufacturing

Teva seeks FDA approval for migraine drug fremanezumab

PBR Staff Writer Published 19 October 2017

Israel-based Teva Pharmaceutical Industries is seeking approval of its migraine drug fremanezumab in the US having filed a Biologics License Application (BLA) with the US Food and Drug Administration (FDA).

Fremanezumab, which is an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody, is intended for the preventive treatment of migraine. The CGRP ligand is considered to be a well-validated target in the neurological condition.

Teva believes that with very few preventive treatment options for migraine available, fremanezumab could become a potential new option in addressing a significantly unmet medical need.

Teva global R&D president and chief scientific officer Michael Hayden said: “The BLA submission for fremanezumab marks a very important milestone for the migraine community.

“There have been few therapeutic innovations for migraine patients in over 25 years. If approved, fremanezumab will be among the first to enter the market in a new class of drugs for the preventive treatment of migraine.”

Teva’s BLA includes data from fremanezumab’s phase 3 HALO clinical studies in which the drug met all its 25 primary and secondary endpoints.

Fremanezumab was found to have generated statistically significant and clinically meaningful results from the late-stage trials held in over 2,000 patients with episodic migraine (EM) and chronic migraine (CM). Both monthly and quarterly dose regimens of fremanezumab were evaluated in the trials in comparison to placebo.

Teva says that the most common adverse events seen in fremanezumab’s clinical trials were injection site induration, pruritis and erythema.

Teva vice president & therapeutic area head, migraine and headache Ernesto Aycardi said: “Phase III clinical studies of fremanezumab demonstrated a significant reduction in the number of migraine and headache days, acute medication use and disability, in addition to demonstrating improvement in quality of life in patients living with episodic and chronic migraine.”

Image: Teva has filed BLA for fremanezumab with FDA for migraine. Photo: courtesy of Teva Pharmaceutical Industries Ltd.