Novartis and Amgen announce FDA approval of Aimovig(TM) (erenumab), a novel treatment developed specifically for migraine prevention

Novartis International AG / Novartis and Amgen announce FDA approval of Aimovig(TM) (erenumab), a novel treatment developed specifically for migraine prevention . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Migraine is a severe neurologic disease that profoundly impacts millions of patients in the United States
   

Aimovig is the first and only FDA-approved treatment to block the calcitonin gene-related peptide receptor (CGRP-R), which plays an important role in migraine
 

Aimovig was consistently shown to reduce monthly migraine days, including in more difficult to treat populations, with many patients achieving at least a 50% reduction

The digital press release with multimedia content can be accessed here:

 

Basel, May 17, 2018 - Novartis today announced that the US Food and Drug Administration (FDA) has approved Aimovig^TM (erenumab) for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic approach as the first and only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R), which is believed to play a critical role in migraine. Aimovig 70 mg is self-administered once monthly via Amgen's device, the SureClick^® autoinjector and does not require a loading dose. Some patients may benefit from a dosage of 140 mg once monthly.

"The FDA approval of Aimovig demonstrates Novartis commitment to bringing meaningful new medicines to patients with complex neurologic diseases, like migraine," said Paul Hudson, CEO Novartis Pharmaceuticals. "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."

In Phase II and III studies in chronic and episodic migraine, Aimovig resulted in significant reductions in monthly migraine days and use of acute migraine medications compared to placebo. These effects on monthly migraine days have been shown to be sustained for up to 15 months in an ongoing open-label extension study in episodic migraine (four to 14 headache days per month).