Novartis files Migraine drug, erenumab, with the EMA

Novartis has filed its migraine drug erenumab with the EMA, putting it in a vital position amongst pharma companies competing to develop a new class of drugs to treat the debilitating condition.

The Swiss drug company has stated that erenumab is the first monoclonal antibody inhibiting calcitonin gene-related peptide (CGRP) to be filed with the European regulator.

Various pharma companies are currently contending to get anti-CGRP drugs to market, with Teva’s rival fremanezumab favoured by most analysts.

Developed in partnership with Amgen, Novartis added that erenumab is the only anti-CGRP antibody that is fully human.

The filing is based on data from four phase 2 and phase 3 clinical studies that involved 2,600 patients who experienced four or more migraine days per month.

In addition to significantly reducing the number of migraine days per month, Novartis also noted that erenumab showed improvements on the impact migraine had on patients’ disability and quality of life when compared with placebo.

Safety was comparable to placebo and an extension trial evaluating long-term safety for up to five years is ongoing.

Novartis and Amgen will co-market the drug, Amgen has exclusive marketing rights in Japan, while Novartis has marketing rights in the rest of the world.

According to Evaluate Pharma, Teva’s TEV-48125, also known as fremanezumab, is slated to be the biggest commercial success in the CGRP inhibitor class, with projected sales of over $1 billion a year in 2022, with Alder’s eptinezumab expected to be close second.

Lilly’s Galcanezumab is forecast to produce sales of $484 million in 2022, with Erenumab raking in around $475 million.

In a statement, Novartis’ chief medical officer, Vas Narasimhan asserted that it hopes to make eranumab “the first new therapy available to migraine patients in over a decade.”

Source – PharmaPhorum

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