Novartis, Amgen Get FDA Nod for Migraine Drug

Novartis AG (ADR) (NVS) today announced that it has received the necessary approval from the U.S. Food and Drug Administration (FDA) for its key drug Aimovig (erenumab) as a preventive treatment of migraine in adults. (See also Blockbuster Potential of Migraine Drugs.)

Preventive Drug Reduces Migraine Days and Need for Medication

The drug works by blocking a compound called calcitonin gene-related peptide receptor (CGRP-R), which is believed to play a critical role in migraine. The drug is available for self-administering once a month using Amgen Inc.’s (AMGN) SureClick auto-injector. The prescribed doses of 70 mg and 140 mg are given monthly dosing.

During the phase 2 and phase 3 clinical trials in patients with chronic and episodic migraine, the use of Aimovig resulted in significant decline in monthly migraine days. Migraine days indicate the period for which an intense headache lasts once started. Compared to a placebo, Aimovig also resulted in a significant reduction in the use of acute migraine medications. Placebo is a substance that has no therapeutic effect, and is used as a control in testing new drugs.

The drug also fared well on the parameters of efficacy, tolerability and safety during the study which involved more than 3,000 patients. 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 almost tripling of the chance of reducing their migraine days by half compared to a placebo.

"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's press release. “Aimovig is the first therapy of its kind targeting the CGRP receptor, and has demonstrated robust efficacy across the spectrum of migraine. We look forward to working closely with Amgen in the U.S. to bring this treatment to physicians and their patients, who could now gain days of their lives back each month."

Migraine, a severe neurologic disease with symptoms of intense headache, impacts millions of patients in the United State.

The two companies, Novartis and Amgen, are also collaborating on associated "The Aimovig Ally Product Support Program". It is aimed at helping patients with necessary insurance coverage and at identifying potential access resources for those who are uninsured or underinsured.

The list price of the drug in the U.S. is set at $575 for once monthly 70 or 140 mg single-use prefilled SureClick auto-injectors, or $6,900 annually. It is expected to be made available in the U.S. within a week’s time.

The company is also expecting a similar approval in the coming months for Aimovig in the EU as its approval application is pending with the European Medicines Agency (EMA).

Novartis shares were trading at $77.48 apiece, while Amgen was quoting at a price of $177.01 during pre-market hours. (See also, Friends or Foes: Amgen and Novartis.)

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