Amgen Wins Race To Migraine Prevention Drug - Lilly, Teva, Alder Trail


The good news is that three other companies-Lilly, Teva, and Alder-have drugs similar to Aimovig either waiting for FDA approval or in the final stages of study.

The drug works by blocking a compound called calcitonin gene-related peptide receptor (CGRP-R), which is believed to play a critical role in migraine.

US regulators Thursday approved the first drug created to prevent chronic migraines.

The World Health Organisation considers migraine to be one of the top ten causes of disability for men and women, and yet, it remains an area of significant unmet medical need. The drug is available for self-administering once a month using Amgen Inc.'s (AMGN) SureClick auto-injector.

We remind investors that Eli Lilly (LLY - Free Report) and Teva Pharmaceutical Industries Limited (TEVA - Free Report) also have anti-CGRP candidates, galcanezumab and fremanezumab, respectively, which are under review in the United States.

Novartis and Amgen seem to have heeded warnings that healthcare payers may baulk at covering the drug if the price was set too high.

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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). The companies expect approval in the European Union in the coming months.

That's compared to the 2.15 and 1.85 day reduction that was observed in the placebo groups. 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.

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

In addition to painkillers and triptans, which ease migraine effects when taken after one starts, preventative treatments for migraines already exist in the form of blood-vessel constrictors and Botox treatments.

The effects on monthly migraine days were shown to be continued for up to 15 months in an ongoing open-label extension study in episodic migraine (four to 14 headache days a month).

The FDA just approved a migraine treatment that's the first of a new class of medications. "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.