Novartis Gets FDA Go-Ahead for Erenumab BLA

Erenumab reduced the number of migraine-affected days per month in phase 2 and 3 studies of more than 2600 patients.

The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Novartis’s erenumab (AMG 344), for the treatment of migraines in patients who experience them four or more days per month.

The drug is expected to be the first and only fully human monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, specifically designed for the prevention of migraine, according to a Novartis statement.

In phase 2 and phase 3 trials of more than 2.600 patients, erenumab showed significant reductions in the number of migraine effected days, acute-medication over-use, and disability. Moreover, the drug improved quality of life for patients with episodic and chronic migraine, Novartis said.

“Migraine is a serious, chronic neurological diseases with a profound and limiting impact on patients’ abilities to carry out everyday tasks,” said Vas Narasimhan, global head drug development and chief medical officer for Novartis. “We look forward to continuing our longstanding history of redefining clinical practice in neurology by working with the FDA to bring erenumab to people suffering from migraine, and to subsequently reduce the overall burden of this debilitating disease.”

Erenumab is the first drug in its category that has been filed with the FDA. It specifically inhibits the receptor of the CGRP, which is thought to play casual role in migraine pathophysiology.

The drug comes as the result of a 2015 partnership between Novartis and Amgen aimed at jointly developing new treatments for migraine and Alzheimer’s disease. In April 2017, the partnership was expanded to include co-commercialization of erenumab in the US.

As part of the partnership, Amgen retains exclusive rights in Japan, and Novartis has exclusive rights in Europe, Canada and the rest of the world.