Novartis’ new migraine therapy accepted for European regulatory review

Novartis has announced that its new migraine therapy has been accepted for review by the European Medicines Agency.

The regulator has validated the company's marketing authorisation application for erenumab, also known as AMG 334, and will now assess the drug for approval as a potential means of preventing migraines.

Erenumab is an anti-CGRP monoclonal antibody and the only fully human antibody of its kind that binds selectively to the CGRP receptor, which is believed to play a key role in mediating the pain associated with migraines.

This regulatory submission is supported by data from four phase II and III clinical studies involving more than 2,600 patients, which have demonstrated the drug's clinically meaningful, statistically significant and sustained efficacy in reducing the number of migraine days per month.

Erenumab has also shown significant improvements on the impact migraines have on patients' disability and quality of life compared to placebo.

Vas Narasimhan, global head of drug development and chief medical officer at Novartis, said the company will be "working with the European health authorities on our goal to make our fully human monoclonal antibody, erenumab, the first new therapy available to migraine patients in over a decade".

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