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18 May 2018, 04:46 | Randall Craig
The FDA has approved the first drug to prevent migraines
Aimovig (erenumab) has been cleared by the USA regulator as a once-monthly, self-injected preventive treatment for migraines based on data from three clinical trials which showed the drug was able to reduce the number of migraine days in a month compared to placebo. Professionals the FDA approved a prophylactic, which affects the peptide calcitonin, a molecule which is involved in the formation of headaches.
"The FDA approval of Aimovig demonstrates Novartis commitment to bringing meaningful new medicines to patients with complex neurologic diseases, like migraine", said Paul Hudson, who heads Novartis pharma division said in the company'spress release.
"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. These are most common among people who are in their 30s, especially the women, and can stay for long hours or in worst cases, even days.
Aimovig is produced by Amgen and Novartis, and it's expected to be available within a week, according to The New York Times.
The first study included 955 participants with a history of episodic migraine and compared Aimovig to placebo. "Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy - with a discontinuation rate of 2% percent due to adverse events - and experienced sustained migraine prevention".
Teva's fremanezumab and Eli Lilly and Co.'s galcanezumab are both awaiting a decision, and Alder's eptinezumab NDA is expected later this year. 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.
Amgen and Novartis are committed to supporting the migraine community and to helping appropriate patients with affordable access to Aimovig. The company found in two studies that patients on the drug had between a 3.6 and 4-day reduction in migraine days per month (to be eligible, patients had to have between 4 and 14 migraine days per month). Atogepant, the company's preventative treatment, is now in phase 2 clinical trials. 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.
The third study evaluated 667 patients with a history of chronic migraine and compared Aimovig to placebo.
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