FDA approves anti-migraine drug from Novartis, Amgen

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In a statement, Novartis said the Federal Drug Administration approved Aimovig's use for the preventive treatment of migraines in adults.

The drug is called Aimovig and is made by pharmaceutical giants Amgen and Novartis.

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

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New treatment options, specifically developed to treat migraine, are making their way, suggesting potential demand for Aimovig. Though sales of the drug have picked up, topping expectations in the company's most recent quarter after receiving an updated label from regulators showing it reduced heart risks, competitors have taken steps to lower prices for similar drugs. Migraine days indicate the period for which an intense headache lasts once started.

Lilly presented phase 3 data in June.

Amgen, an American company based in California, said a study in difficult-to-treat patients - those with episodic migraines who failed two to four prior treatments - showed that those given Aimovig had almost three-fold higher odds of having their migraine days cut by half or more as compared to placebos. The companies expect approval in the European Union in the coming months. Over the course of six months, Aimovig-treated patients experienced, on average, one to two fewer monthly migraine days than those on placebo.

In May 2017, Lilly reported that galcanezumab succeeded in the EVOLVE-1, EVOLVE-2, and REGAIN trials.

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The drug's effectiveness for the preventive treatment of migraine was assessed in various global, randomized, double-blind, placebo-controlled trials. Atogepant, the company's preventative treatment, is now in phase 2 clinical trials.

The latest drug has shown significant results on the people who have issues with the episodic and chronic migraine attacks. This is because Teva's manufacturing partner for fremanezumab, Celltrion, which makes the API, received a warning letter from the FDA this year that delayed the approval of the drug.

This article was originally published by Business Insider.

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