Friday, 22 June, 2018

US OK's first-in-class drug Aimovig for migraine prevention

1819 A man suffering from a headache is tormented by a horde of little demons. 'Headache' by Cruikshank 1819 A man suffering from a headache is tormented by a horde of little demons. 'Headache' by Cruikshank
Marlene Weaver | 18 May, 2018, 16:47

Amgen Inc announced Thursday the US Food & Drug Administration has approved Aimovig or erenumab-aooe for the preventive treatment of migraine in adults.

The drug is the first FDA-approved treatment, specifically developed to treat migraine by blocking calcitonin gene-related peptide ("CGRP") receptor.

"Cluster headache can be hard to evaluate in clinical studies, which has contributed to few available treatment options for clusterheadache, often considered the most severe pain one can experience", noted Christi Shaw, president of Lilly Bio-Medicines, in the release.

The new treatment, which can be administered with an autoinjector, should now be available within a week.

Teva's fremanezumab and Eli Lilly and Co.'s galcanezumab are both awaiting a decision, and Alder's eptinezumab NDA is expected later this year.

Representatives of the American Management on sanitary inspection behind quality of foodstuff and medicines has issued a statement about the fact that regular injections of the new drug is able to relieve patients from headaches and chronic migraines.

Amgen codeveloped Aimovig with Novartis, and are one of four companies pursuing regulatory approval of CGRP inhibitors for the prevention of migraine.

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Injection site reactions and constipation were the most common adverse reactions in clinical studies of Aimovig.

The effectiveness of Aimovig for the preventive treatment of migraine was evaluated in three clinical trials.

The approval for sale in the European Union is expected in the next few months. Thirty percent of those in trials reported a halving or better of their migraines, and a lucky few had the pain stop entirely, but most experienced more modest benefits.

Results show that patients taking the drug had nearly three-fold higher odds of having their migraine days cut by half or more compared to placebo, with more than twice as many patients taking Aimovig achieving this reduction (30.3 percent versus 13.7 percent, respectively).

That's compared to the 2.15 and 1.85 day reduction that was observed in the placebo groups. While out-of-pocket costs will vary based on patient insurance status, Amgen and Novartis have launched the Aimovig Ally program and Aimovig Copay Program to help reduce costs to as low as $5 per month for commercially-insured patients and help uninsured patients identify potential access resources.

The second study included 577 patients with a history of episodic migraine and compared Aimovig to placebo.

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