Medical

FDA approves the use of first drug developed to treat chronic migraines

FDA approves the use of first drug developed to treat chronic migraines

Amgen/Novartis have been awaiting an FDA decision on their collaborative erenumab (Aimovig), a calcitonin gene-related peptide (CGRP) monoclonal antibody for the prevention of migraine since they submitted a BLA for the novel treatment last July.

The stock prices of Amgen (amgn) and Novartis (nvs) have popped after the pharmaceutical companies won USA approval for a new shot that treats migraines. The condition is three times more common among women than men.

In a study, patients who were administered with the Aimovig shot saw that their migraine days were reduced from eight days to four days in a month on an average. In a dedicated study with patients with difficult-to-treat conditions - like those with episodic migraine who have failed two to four prior treatments - a dose of Aimovig 140 mg resulted in an nearly tripling of the chance of reducing their migraine days by half compared to a placebo.

Those who got the medication had on average 3.7 fewer migraine days per month, compared to 2.2-day reduction in the placebo group.

Companies including Teva Pharmaceutical Industries and Eli Lilly & Co are developing similar treatments.




Novartis and Amgen seem to have heeded warnings that healthcare payers may baulk at covering the drug if the price was set too high. 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 US regulator said the effectiveness of the new drug was tested in three clinical trials. These drugs aim to block it cut down on the number of migraine days patients suffer each month. Atogepant, the company's preventative treatment, is now in phase 2 clinical trials.

The company's Phase III HALO study evaluating the efficacy, safety, and tolerability of both quarterly and monthly subcutaneous dosing regimens of fremanezumab, compared to placebo, for the prevention of episodic migraine were released online by JAMA.

In a statement on Thursday, Express Scripts said migraine patients have a serious unmet need, but "not everyone will need this drug" and it will have a program in place to make sure the medication is authorized for only the appropriate patients.

As a migraine treatment Botox costs around $3,500 per year, and analysts predict that the annual price for Aimovig will drop to around $5,000 with rebates and discounts.


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