US OK's first-in-class drug Aimovig for migraine prevention

Faith Castro
May 18, 2018

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 is the first FDA-approved treatment, specifically developed to treat migraine by blocking calcitonin gene-related peptide ("CGRP") receptor.

Shares of drugmakers Amgen Inc. and Novartis AG rose in after-hours trading Thursday after jointly announcing FDA approval of Aimovig, a first-of-its-kind treatment for migraines. Aimovig will be available in a pre-filled self-administering autoinjector, SureClick, for a once monthly 70 mg dosage.

"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".

The most common side effects reported by patients in the trials were injection site reactions and constipation.

The two companies, Novartis and Amgen, are also collaborating on associated "The Aimovig Ally Product Support Program". The companies expect approval in the European Union in the coming months.

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Erenumab consistently demonstrated an ability to reduce monthly migraine days in patients with episodic and chronic migraine in 3 major clinical trials, ARISE, STRIVE, and LIBERTY.

In addition, participants reporting ≥ 50% reduction in the monthly average number of migraine days achieved significantly greater results in monthly (47.7%, P 0.001) and quarterly (44.4%, P 0.001) dosing compared with placebo (27.9%). Atogepant, the company's preventative treatment, is now in phase 2 clinical trials. 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.

The second study included 577 patients with a history of episodic migraine and compared Aimovig to placebo.

Amgen's pricing strategy "appears to play into (an) appropriate framework of lower gross pricing", Jefferies analyst Michael Yee said in a research note.

Aimovig and the migraine drugs in development target a substance called CGRP whose levels spike in the blood during a migraine, triggering symptoms.

Aimovig is the first in a new class of treatments created to prevent migraine by interfering with calcitonin gene-related peptide (CGRP), which is involved in the processes that kick off a migraine, such as dilation of blood vessels in the brain.

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