Erenumab (AIMOVIG™, erenumab-aooe) was launched in the US in July 2018, following its first global approval in the region in May, which was reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Also in May 2018, the agent received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

Erenumab, developed by Amgen and Novartis, is a novel, first-in-class drug that blocks the calcitonin gene-related peptide receptor (CGRP-R) that is thought to play a critical role in the development of migraines. [3] The agent is dispensed as a self-administered subcutaneous injection given once monthly via a SureClick® autoinjector (an Amgen device) as a preventative medicine.[4]

The positive CHMP opinion adopted is for the use of erenumab as prophylaxis in adults who have at least 4 migraine days per month.[5]

According to one source, migraine affects 1 in 10 people globally.[6]  In addition to moderate to severe head pain, migraines are often associated with nausea, vomiting, visual anomalies, and sensitivities to light, sound and odours. Collectively these can be very debilitating and result in reduced quality of life and increased personal and societal financial burdens. [4] [3]

“We need new treatments for this painful and often debilitating condition,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Aimovig provides patients with a novel option for reducing the number of days with migraine,” he explained.[3]

“Having a treatment designed to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine,” stated Stewart J. Tepper, MD, Professor of Neurology at the Geisel School of Medicine at Dartmouth Medical School. [4]

The FDA approval and CHMP positive opinion were based on results from three placebo-controlled clinical trials including almost 2,200 patients with a history of chronic migraine. The most frequently reported adverse events included injection site irritation and constipation.[2] [3]

For further information related to the first approval of erenumab please visit Drugs[1], or to learn more about the overall development of the drug across all indications visit AdisInsight[2].

Image credit:  Grace Madeline – Unsplash

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