If Approved, Aimovig Could Strengthen Amgen’s Neurology Portfolio
Clinical trial with Aimovig
In September 2017, Amgen presented new data from the pivotal Phase 2 trial with Aimovig, which demonstrated additional evidence of the safety and efficacy of Aimovig for the prevention of a migraine.
Presently, Aimovig is the only biologic product under investigation that has been designed specifically to prevent a migraine by inhibiting the CGRP (calcitonin gene-related peptide) receptor.
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Aimovig clinical trial results
The pivotal Phase 2 trial with Aimovig demonstrated that the drug substantially reduced the number of monthly migraine days (or MMDs) in patients who did not respond adequately to prior preventive therapies. The outcomes from the dedicated study in patients with stable angina additionally strengthen the safety profile of Aimovig.
In the pivotal Phase 2 study at the end of 12th week, patients who did not adequately respond to prior preventive therapies when administered Aimovig 140 mg and Aimovig 70 mg, respectively, showed 7.0 days and 5.4 days reduction in MMDs compared to 2.7 days for patients on placebo. In the trial, Aimovig also did not show an adverse event in more than 5% of the patients treated with the drug.
Amgen has already filed the regulatory submissions to the FDA and the European Commission. The FDA has provided the Prescription Drug User Fee Act (or PDUFA) action date of May 17, 2018.
In the US, if the drug receives approval, Novartis (NVS) and Amgen (AMGN) would jointly commercialize Aimovig. Amgen holds the exclusive marketing rights in Japan while Novartis holds exclusive marketing rights in the rest of the world.
Amgen’s peers in the neurology drugs market include Biogen (BIIB), Johnson & Johnson (JNJ), Pfizer, Teva Pharmaceuticals, and Eli Lilly. The iShares Core S&P 500 ETF (IVV) invests ~0.63% of its total portfolio holdings in Amgen.