FDA approved a new drug to prevent migraine problems

FDA approved a new drug to prevent migraine problems

FDA approved a new drug to prevent migraine problems

Aimovig, a drug that promises preventive treatment of migraine in adults, has been now approved by The US Food and Drug Administration.

Amgen has a different take on the cost, arguing in a statement; "The price of Aimovig reflects the value it brings to patients and society, including the financial impact on sufferers, caregivers, and employers, while also factoring in critical issues such as patient affordability, and fair and timely access".

"Aimovig provides patients with a novel option for reducing the number of days (spent suffering) with migraine", said Eric Bastings, deputy director of the division of neurology products in the FDA's Center for Drug Evaluation and Research.

The new treatment, which can be administered with an autoinjector, should now be available within a week. An estimated 38 million Americans have migraines, and around a third of those people would be eligible for preventive treatment. The officials said that the hiked price of the drug will depict its huge importance in the patient's life.

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Lilly presented phase 3 data in June. However, most of the migraine patients avoid using these treatments as they do not help them get enough relief or tend to cause severe side effects. Specifically, during the 12-week period after the first dose, monthly migraine days were significantly reduced to 4.6 days for monthly (p 0.001) and 4.9 days for quarterly (p 0.001) dosing compared with 5.9 days for placebo, according to the company's release. Moreover, since trial participants in the control group reported a substantial, although smaller, improvement, it appears part of the benefit comes from the placebo effect. Patients treated with erenumab-aooe experienced 1 to 2 fewer monthly migraine days on average compared with those on placebo.

"We are engaged in a constructive dialogue with the FDA in close collaboration with our partner Celltrion", Teva stated in its announcement of first-quarter 2018 results.

Three other companies with matching medicines that use the same molecule blocker have also reached the final stages of the FDA's approval process. Once they hit the market, the price for all the migraine prevention drugs could decrease. Atogepant, the company's preventative treatment, is now in phase 2 clinical trials. It has called for Amgen to reconsider its strategy of setting a high list price for new drugs and then lowering the cost of health plans through hefty rebates.

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