Friday, June 1, 2018, at 15:45
Novartis has announced that the European Medicines Agency (EMA) Committee on Human Use Medicines (CHMP) has recommended Aimovig (erenumab) approval to prevent migraine in adults suffering at least 4 days of migraine per month.
The World Health Organization (WHO) has mentioned migraine as one of the top ten causes of years of disability worldwide. Aimovig is the first treatment of its kind specifically developed to prevent migraine, blocking the peptide related to the calcitonin gene (CGRPR), which plays an essential role in the pathology of migraine. If approved, Aimovig will be administered once a month by Autoinjector.
"It is exciting to be closer to being able to offer in Europe the first targeted therapy for
Prevent migraine, "said Paul Hudson, CEO of Novartis Pharma. "If approved, patients suffering from this disease may stop using preventive treatments directed to other conditions, often associated with poor tolerability and lack of efficacy. With Aimovig, physicians will be able to offer these patients a preventive therapeutic option Safe, effective and well tolerated"
The positive view of the CHMP is based on a solid set of data, including four Phase II and III trials conducted in more than 2,600 patients experiencing four or more days with migraines a month.
Aimovig showed clinical and statistically significant benefits compared to placebo in reducing the number of days with migraine per month in the spectrum of migraine, providing patients with more days free from these pains.
In the clinical program, half of patients with episodic migraine (4-14 days with migraine per month) who took Aimovig reduced their days with migraine by half or more, a significantly higher percentage compared to placebo (Strive: 43.3 and 50 percent with Aimovig 70mg and 140mg respectively; Placebo: 23 percent, p < 0.001).
Patients with chronic migraine (15 or more days with migraine per month) achieved a statistically significant and similar response (40 and 41 percent with Aimovig® 70mg and 140mg respectively, placebo: 23 by the way, p < 0.001).
Effective and Safe
The efficacy, tolerability and safety of Aimovig has already been evaluated in clinical studies in those who participated, more than 3,000 patients. This number includes the CHMP data set and other studies, such as the ' Liberty ', a study designed for difficult-to treat populations (those suffering from episodic migraine and who have failed from 2 to 4 pre-emptive treatments).
In the ' Liberty ' study, patients taking Aimovig 140 mg were three times more likely to reduce their days with migraine by half or more, compared to placebo. In all studies, Aimovig's safety and tolerability profile was comparable to that of placebo, including a study devoted to evaluating cardiovascular safety in patients with stable angina (exercise-induced).
Already sold in the U.S.A
The European Commission will review the opinion of the CHMP and issue its final decision, which usually takes place in three months. This resolution will be applicable in the 28 member states of the European Union and also in Iceland, Norway and Liechtenstein. Aimovig received approval from the U.S. Food and Drug Administration (FDA) on May 17, 2018 and there are more applications for registration in progress with other health authorities around the world.
Novartis has created an access program for Aimovig, such as "part of the company's commitment to provide patients with safe and immediate access, in accordance with the local regulations of the health authorities and the laws in force when the product is not yet Available ", they explain.
Novartis and Amgen currently market and jointly Aimovig in the U.S. Amgen has the exclusive marketing rights of the drug in Japan and Novartis has exclusive marketing rights in the rest of the world.