FDA accepts Amgen’s BLA for Aimovig (erenumab)

kind, according to the company: a monoclonal antibody that inhibits the calcitonin gene-related peptide receptor.  Data was gleaned from studies involving over 2,600 patients.
kind, according to the company: a monoclonal antibody that inhibits the calcitonin gene-related peptide receptor. Data was gleaned from studies involving over 2,600 patients. | File photo

California-based Amgen recently obtained U.S. Food and Drug Administration acceptance of its Biologics License Application for Aimovig (erenumab), a product developed specifically to help victims of frequent migraine headaches.

The medication, intended to prevent migraines in patients with four or more episodes monthly, is the first of its kind, according to the company: a monoclonal antibody that inhibits the calcitonin gene-related peptide receptor.

Data was gleaned from studies involving over 2,600 patients, including Phase 2 and Phase 3 clinical studies comparing Aimovig to a placebo. Results demonstrated fewer migraine attacks, less disability and reduced acute medication use among patients with episodic and chronic migraine.

"Migraine is a serious neurological disease that has a substantial economic burden for both patients and the health care system, yet it continues to be under-recognized and under-treated," Dr. Sean Harper, Amgen’s executive vice president of research and development, said. "We are pleased to advance Aimovig, our migraine-specific preventive therapy, to help address the unmet need in this community and potentially mitigate the overall burden of this disease for patients who have already tried other therapeutic options."

Aimovig will be marketed in the United States by Amgen in conjunction with Novartis.

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