Therapy Areas: Inflammatory Diseases
FDA Grants Amgen Approval for Aimovig (erenumab-aooe) for Migraine Prevention
22 May 2018 - - Thousand Oaks, California-based human therapeutics developer Amgen (NASDAQ: AMGN) has received US Food and Drug Administration approval for Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults, the company said.
Aimovig was specifically developed to prevent migraine by blocking the CGRP-R, which is associated with migraine.
Studied in several large global, randomized, double-blind, placebo-controlled studies to assess its efficacy and safety in migraine prevention, more than 3,000 patients have participated in the Aimovig clinical program across four placebo-controlled Phase 2 and Phase 3 clinical studies and their open-label extensions.
Aimovig was consistently shown to reduce monthly migraine days, including in more difficult-to-treat populations, with many patients achieving at least a 50% reduction of monthly migraine days from baseline over the last four weeks of the double-blind treatment phase of the study.
Amgen discovers, develops, manufactures, and delivers human therapeutics worldwide.
It offers products for the treatment of illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.
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