Drug To Prevent Chronic Migraine Gets FDA Approval

19 May, 2018, 04:37 | Author: Billie Castillo
  • The FDA has approved the first drug to prevent migraines

Food and Drug Administration (FDA) for its key drug Aimovig (erenumab) as a preventive treatment of migraine in adults.

Aimovig 70 mg is self-administered once monthly through Amgen's SureClick autoinjector device, and a loading dose is not required.

Eric Bastings, a deputy director in the FDA Center for Drug Evaluation and Research has to say that Aimovig provides patients with a novel option for reducing the number of days with a migraine.

"The FDA approval of Aimovig demonstrates Novartis commitment to bringing meaningful new medicines to patients with complex neurologic diseases, like migraine", said Paul Hudson, who heads Novartis pharma division said in the company's press release.

Over the course of six months, Aimovig-treated patients experienced on average one to two fewer monthly migraine days than those on placebo. However, there were side-effects too - namely injection-site reactions and constipation. Aimovig has shown effective results in patients with chronic and episodic migraine problems and has reduced the headache by 99.9% at the first use.

The treatment is given by monthly self-injections.

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The drug also fared well on the parameters of efficacy, tolerability and safety during the study which involved more than 3,000 patients. The drug named, Aimovig is given on a monthly basis by self-injections and will be priced at United States dollars 6,900 annually or USD 575 monthly.

Similarly, companies like Eli Lilly & Co. and Teva Pharmaceutical Industries are also working to produce medicine aligned to Aimovig.

"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. Migraine days indicate the period for which an intense headache lasts once started. However, earlier this month, Teva informed that it does not expect to get FDA approval for fremanezumab on its PDUFA date in June. The companies expect approval in the European Union in the coming months.

Given the tens of millions of people who suffer from migraines, the average reduction of one migraine a month, rising to 2.5 per month among chronic sufferers, could still make a major difference to global quality of life.

Aimovig has been developed by Amgen Inc. of Thousand Oaks and Novartis AG.

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