Roche’s Ocrevus accepted for EU and US regulatory review

Roche has announced that its new multiple sclerosis (MS) drug Ocrevus has been accepted for regulatory review in the US and Europe.

The European Medicines Agency (EMA) has validated the company's marketing authorisation application for Ocrevus, which is intended for the treatment of relapsing MS (RMS) and primary progressive MS (PPMS), while the US Food and Drug Administration (FDA) has also accepted a biologics licence application the same indications.

In the US, the drug has received priority review designation, based on its potential to deliver significant improvements in the safety and effectiveness of treating a serious disease.

If approved by the EMA and FDA for both indications, Ocrevus would be the first and only treatment for both of these forms of MS, which affect approximately 95 percent of people at diagnosis.

Dr Sandra Horning, chief medical officer and head of global product development at Roche, said: "We will continue to work closely with the EMA and FDA to bring this investigational medicine to people with MS as quickly as possible."

This comes after Roche's Gazyvaro was approved in Europe in combination with bendamustine for people with previously treated follicular lymphoma earlier this month.