Monday, 20 August, 2018

Amgen's Migraine Drug Aimovig Gets FDA Approval, Shares Up

05032015_migraine_headache_wiki Health News Prevention from
Johnnie Parks | 18 May, 2018, 16:46

During the phase 2 and phase 3 clinical trials in patients with chronic and episodic migraine, the use of Aimovig resulted in significant decline in monthly migraine days.

A new medicine that is created to prevent the onset of a migraine was approved by the Food and Drug Administration on Thursday. Professionals the FDA approved a prophylactic, which affects the peptide calcitonin, a molecule which is involved in the formation of headaches.

"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. Data from a phase IIIb LIBERTY study in episodic migraine patients who failed two to four prior treatments showed that Aimovig has three times higher probability of reducing migraine days by half compared to placebo. The drug is available for self-administering once a month using Amgen Inc.'s (AMGN) SureClick auto-injector.

In Europe, migraine sufferers will have to wait a little longer for access to the drug, with the EMA due to complete its ongoing review of Aimovig in the next few months.

FDA approves Aimovig (erenumab-aooe), a novel treatment developed specifically for migraine prevention [press release]. The most commonly reported adverse events through all trials have been injection site reactions and constipation.

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Teva, Eli Lilly and a small biotech called Alder Biopharmaceuticals are also developing rival CGRP drugs, and the FDA is to make a decision on the first two later this year. "Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success", said Stewart Tepper, professor of Neurology at the Geisel School of Medicine at Dartmouth Medical School.

Amgen Inc is also in collaboration with the Swiss pharmaceutical firm Novartis that can help in commercializing the medication rapidly and across the globe.

Lilly's combined studies evaluated more than 340 patients, representing the largest controlled preventive trials conducted in cluster headache to date.

The approval for sale in the European Union is expected in the next few months. But it's known well among the migraine-afflicted that there is not medicine to treat or prevent these severely debilitating episodes that some patients can see coming.

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