Amgen (AMGN - Free Report) announced that its fully human monoclonal antibody, Aimovig (erenumab), met all primary and secondary endpoints in a unique phase IIIb study for prevention of patients with episodic migraine, who have failed multiple prior preventive treatments.
Notably, Aimovig is the only investigational therapy designed to selectively block the calcitonin gene-related peptide (CGRP) receptor, which plays a significant role in migraine activation.
Aimovig is under review in both the United States and the EU for prevention of both episodic and chronic migraine. A decision from the FDA is expected on May 17, 2018.
Moreover, shares of the company are up 25.8% in a year, comparing favorably with the industry’s an increase of 8.6%.
The phase IIIb LIBERTY study was designed to evaluate the efficacy and safety of Aimovig in a broad spectrum of migraine patients ranging from those without a preventive treatment as well as those, who have tried and failed such therapies.
Results from the study demonstrated that at least 50% of patients achieved reduction of monthly migraine, days from the baseline over the last four weeks compared with placebo, the primary endpoint of the study. Data from the trial also showed consistent efficacy, safety and tolerability of Aimovig across a wider spectrum of migraine patients including those with complicated cases.
We remind investors that Amgen developed Aimovig in collaboration with Novartis (NVS - Free Report) . The companies have now agreed to combine capabilities to co-commercialize the candidate in the United States. Incidentally, Amgen retains its exclusive commercialization rights in Japan. Novartis, which retains its existing commercialization rights in rest of the world, has exclusive rights to commercialize Aimovig in Canada under the expanded deal.
Per the World Health Organization, migraine is one of the most debilitating illnesses. Approximately 10 million Americans’ daily activities are affected by frequency or severity of migraine. Around 3.5 million subjects are undergoing a preventive therapy, of which, 80% discontinues the treatment within a year. Hence, approval of Aimovig will provide the company a much-needed access to a huge patient population in the United States, who are in need of additional curative options to apprehend the disease.
However, several companies including Teva Pharmaceutical Industries Limited (TEVA - Free Report) and Allergan (AGN - Free Report) among others are also developing migraine treatments targeting CGRP.
Amgen carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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