Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for Aimovig (erenumab) for the prevention of migraine in adults who have at least four migraine days per month. The World Health Organisation (WHO) has listed migraine as one of the top ten causes of years lived with disability worldwide. Aimovig is the first treatment of its kind specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R), which plays a critical role in migraine. If approved, Aimovig will be self-administered once every four weeks via an auto-injector pen.
"We are excited to be one step closer to bringing the first targeted migraine prevention therapy to patients in Europe," said Paul Hudson, Chief Executive Officer at Novartis Pharma. "If approved, patients suffering from migraine will no longer have to rely on preventive treatments repurposed from other diseases that are often associated with poor tolerability and lack of efficacy. With Aimovig, physicians may soon provide these patients with an option for a safe, effective and well-tolerated migraine prevention treatment."
The CHMP positive opinion is based on a robust data package, including four Phase II and III clinical studies of more than 2,600 patients experiencing four or more migraine days per month. Aimovig demonstrated clinically meaningful and statistically significant benefits versus placebo in reducing the number of migraine days per month across the spectrum of migraine, giving patients more migraine free days of their lives back. In the clinical program, half of patients with episodic migraine (4-14 monthly migraine days) taking Aimovig had their number of migraine days cut by half or more, a significantly higher percentage compared to placebo (STRIVE: 43.3% and 50% Aimovig 70mg and 140mg respectively; placebo: 26.6%, p<.001). Patients with chronic migraine (15 or more monthly migraine days) achieved a similar, statistically significant response (40% and 41% Aimovig 70mg and 140mg respectively, placebo: 23%, p<.001)
The safety, efficacy and tolerability of Aimovig have now been assessed in clinical studies involving more than 3,000 patients. This number includes the CHMP data package and further studies such as LIBERTY, a dedicated study in difficult-to-treat populations - those with episodic migraine who have failed two to four prior treatments. In LIBERTY, patients taking Aimovig 140 mg had significantly higher likelihood of having their migraine days cut by half or more compared to placebo. Across all studies, the safety and tolerability profile of Aimovig was comparable to placebo, including in a dedicated study assessing cardiovascular safety in patients with stable (exercise-induced) angina
The European Commission will review the CHMP opinion and usually delivers its final decision within three months. The decision will be applicable to all 28 European Union member states plus Iceland, Norway and Liechtenstein. Aimovig received FDA approval on May 17, 2018 and additional regulatory filings are underway with other health authorities worldwide. Novartis has created a patient access program for Aimovig, as part of the company's commitment to provide patients with safe and timely access in accordance with local health authority regulations and applicable laws in cases where the product is not or not yet available.
Novartis and Amgen are co-commercialising Aimovig in the US Amgen has exclusive commercialisation rights to the drug in Japan and Novartis has exclusive rights to commercialise in the rest of the world.