Migraine Space in Focus as AMGN/NVS' Aimovig Gets FDA Nod
Migraine is a serious neurological disease, which has significant effects on patients’ daily life. Patients suffer from debilitating pain and physical impairment along with fear of the next attack. It is estimated that patients with frequent migraine attacks may lose more than half of their life to the disease.
Last week, Amgen AMGN and partner Novartis NVS announced FDA approval for their drug, Aimovig (erenumab) for the prevention of migraine. Aimovig is the first FDA-approved drug specifically developed for the treatment of migraine by blocking calcitonin gene-related peptide ("CGRP") receptor.
The approval was based on positive data from several mid- and late-stage studies.
The drug achieved significant reduction in monthly migraine days and use of acute migraine medications compared to placebo, per data from these studies. Moreover, Aimovig showed three times higher probability in reducing migraine days by half compared to placebo in patients with episodic migraine patients and who failed two to four prior treatments.
With the approval of Aimovig, investors’ focus has shifted to CGRP drugs/candidates for the treatment of migraine. Eli Lilly LLY and Teva Pharmaceutical Industries Limited’s TEVA respective anti-CGRP candidates, galcanezumab and fremanezumab are under review in the United States. Alder BioPharmaceuticals, Inc. ALDR is also developing its anti-CGRP candidate, eptinezumab, for treating migraine.
Alder, in its first-quarter regulatory filing, stated that there are approximately 36 million people living with this serious neurological disease in the United States alone, including five to six million with episodic and chronic migraine. Migraine is ranked among the top 10 causes of years lived with disability worldwide.
However, the traditional preventive therapies have tolerability limitations along with several side-effects. This represents a huge unmet need for new anti-CGRP therapies like Aimovig and other under review candidates. Per a CNBC article and Alder’s regulatory filing, the migraine market will be worth $1 - $2 billion in the next few years.
Amgen has priced Aimovig at $575 for a once monthly 70 or 140 mg single-use prefilled SureClick autoinjector or $6,900 annually. The price will certainly pinch patients and thus the acceptance of the drug remains to be seen. However, insurance coverage along with Aimovig copay program may significantly bring down the cost. Moreover, potential approval to galcanezumab and fremanezumab in the coming months will increase competition, which may put downward pressure on pricing.
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