US FDA approves Amgen migraine drug, price set at $6900/yr

US FDA approves Amgen migraine drug, price set at $6900/yr

In Phase II and III studies in chronic and episodic migraine, Aimovig was demonstrated to reduce monthly migraine days, including in more difficult-to-treat populations, with majority of patients achieving about a 50% reduction.

Aimovig is produced by Amgen and Novartis, and it's expected to be available within a week, according to The New York Times.

"Having a treatment created to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine", said Stewart J. Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth Medical School in New Hampshire, in a statement.

"The drugs will have a huge impact", said Dr. Amaal Starling, a neurologist and migraine specialist at the Mayo Clinic in Phoenix. It will cost US$6,900 a year. An estimated 38 million Americans have migraines, and around a third of those people would be eligible for preventive treatment.

Amgen and Novartis have claimed the first approval for a CGRP inhibitor in migraine, getting an FDA green light for their Aimovig product ahead of rival drugs from Eli Lilly, Teva and Alder Biopharma. "This is really an wonderful time for my patient population and for general neurologists treating patients with migraine".

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Until now, drugs used to prevent migraines were created to treat other diseases, like high blood pressure. In a second study involving nearly 580 patients, participants using the drug experienced one fewer migraine day per month on average during a three month period. The companies expect approval in the European Union in the coming months.

The first study included 955 participants with a history of episodic migraine and compared Aimovig to placebo.

Allergan is developing CGRP- targeting drugs to both treat migraines when they're happening and prevent them. It's the first in a new class of long-acting drugs for preventing migraines. The co-pay burden is one of the key targets in President Trump's blueprint to lower drug prices in the US.

"Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy - with a discontinuation rate of two percent due to adverse events - and experienced sustained migraine prevention".

Pharmaceutical middleman Express Scripts is putting pressure on the makers of these drugs to forgo higher list prices and get refunded if the drugs don't work over a set period of time.

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