FDA approves Amgen migraine drug, price set at $6900 per year


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

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

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. There is a need to add more treatment plans for this painful and often debilitating condition. 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 70 mg is self-administered once monthly via Amgen's device, the SureClick autoinjector, and does not require a loading dose.

According to an FDA release, the monoclonal antibody was evaluated in three clinical trials that demonstrated effectiveness for those with episodic and chronic migraine compared to placebo.

We remind investors that Eli Lilly (LLY - Free Report) and Teva Pharmaceutical Industries Limited (TEVA - Free Report) also have anti-CGRP candidates, galcanezumab and fremanezumab, respectively, which are under review in the United States. Over the course of three months, Aimovig-treated patients experienced, on average, one fewer migraine day per month than those on placebo. However, there were side-effects too - namely injection-site reactions and constipation.

Amgen and Novartis are committed to supporting the migraine community and to helping appropriate patients with affordable access to Aimovig. The companies expect approval in the European Union in the coming months.

The effects on monthly migraine days were shown to be continued for up to 15 months in an ongoing open-label extension study in episodic migraine (four to 14 headache days a month).

Aimovig is the first in a new class of treatments created to prevent a migraine by interfering with calcitonin gene-related peptide (CGRP), which is involved in the processes that kick off the severe headaches, such as dilation of blood vessels in the brain. CGRP has been known to play a significant role in migraines since the 1980s and 1990s, though it's taken some time to develop the technology that can leverage it.

In fact, 85 percent of migraine patients stop taking drugs for the disorder within a year.