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

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 generelated 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 Basel, May 17, 2018 –

Novartis today announced that the US Food and Drug Administration (FDA) has approved Aimovig™ (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 selfadministered 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). The efficacy, tolerability and safety of Aimovig has been assessed in more than 3,000 patients, including in a Phase IIIb study (LIBERTY) and an ongoing open-label extension of up to five years in duration. In LIBERTY, a dedicated study in difficult-to-treat populations – those with episodic migraine who have failed two to four prior treatments – patients taking Aimovig 140 mg had nearly three-fold higher odds of having their migraine days cut by half or more compared to placebo1 . In clinical studies of Aimovig, the most common adverse reactions were injection site reactions and constipation. “Having a treatment designed to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine. Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success,” said Stewart J. Tepper, MD, Professor of Neurology at the Geisel School of Medicine at Dartmouth Medical School. “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.” Amgen and Novartis are committed to supporting the migraine community and to helping appropriate patients with affordable access to Aimovig. The Aimovig Ally™ product support program has been created to help patients navigate insurance coverage and identify potential access resources for those who are uninsured or underinsured. The U.S. list price of Aimovig is $575 for once monthly 70 or 140 mg single-use prefilled SureClick® autoinjectors, or $6,900 annually. The price of Aimovig reflects the value it brings to patients and society, including the financial impact on sufferers, caregivers and employers, while also factoring in critical issues such as patient affordability, and fair and timely access. Aimovig is expected to be available to patients in the U.S. within one week. The European Medicines Agency (EMA) Marketing Authorization Application (MAA) for Aimovig is under review. Novartis expects approval in the EU in the coming months. About AimovigTM (erenumab) Aimovig is the 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. AimovigTM has been studied in several large, global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention. More than 3,000 patients have participated in our overall clinical trial program across the four placebo-controlled Phase II and Phase III clinical studies and their open-label extensions.