Amgen's Biologic Aimovig (Erenumab) Receives Approval in the U.S.
Amgen's Biologic Aimovig (Erenumab-Aooe) Receives Approval in the U.S.
In a SEC filing Monday, Amgen said the parties were updating the terms of their Aimovig collaboration and settling their dueling lawsuits related to the deal.
Amgen has announced new data from the HER-MES Phase IV study, the first and only head-to-head study of Aimovig® (erenumab-aooe), a calcitonin gene-related peptide (CGRP) inhibitor, against topiramate for adult patients with episodic and chronic migraine.
Tuesday, AbbVie said the FDA has green-lighted its Qulipta, or atogepant, for prevention of episodic migraine. The go-ahead follows the landmark approval of Biohaven’s Nurtec ODT as the first oral anti-CGRP drug for preventing migraine, setting up a direct battle between two meds that both bear big sales expectations.
One of the gems AbbVie inherited from the $63 billion Allergan transaction is ready to take a slice of the highly competitive migraine market—and no, it’s not Botox.
Aimovig is the first and only approved treatment in Japan to block the calcitonin gene-related peptide receptor (CGRP-R), which is believed to play a critical role in migraine. This is also the first independent submission and approval for Amgen K.K., a wholly owned affiliate of Amgen Inc. headquartered in Tokyo.
Amgen (NASDAQ:AMGN) today announced that the Japanese Ministry of Health, Labour and Welfare has granted marketing approval for Aimovig® (erenumab) for the suppression of onset of migraine attacks in adults. Aimovig is the first and only approved treatment in Japan to block the calcitonin gene-related peptide receptor (CGRP-R), which is believed to play a critical role in migraine.3 This is also the first independent submission and approval for Amgen K.K., a wholly owned affiliate of Amgen Inc. headquartered in Tokyo.
Novartis and Amgen were the first onto the CGRP scene with migraine drug Aimovig, but tensions ensued shortly into the drug's launch as both partners filed dueling lawsuits against each other. But now with the migraine market becoming increasingly crowded, Novartis will cede U.S. Aimovig operations over to Amgen.
Novartis has announced that first Phase IV HER-MES study of Aimovig (erenumab) against topiramate in patients with episodic and chronic migraine met its primary and secondary endpoints.