A new medication from Roche for multiple sclerosis is under review by the FDA.
Roche’s new multiple sclerosis drug, which targets a form of the disease that currently has no treatments, has been given a hurry-up status from the FDA as it looks to start earning on its blockbuster potential.
The regulator has granted Ocrevus (ocrelizumab) a priority review, speeding up the FDA’s process–which should see the drug gain a U.S. green light by 28 December, months ahead of the Swiss firm’s original goal date.
The med is seeking a license for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
RMS already has a number of treatments on the market from Novartis ($NVS), Biogen ($BIIB), German Merck, Sanofi ($SNY), Teva ($TEVA) and others–but there are currently no drugs on the market for the progressive form of the disease, which makes up around 10-15% of all MS patients.
The drug, administered by intravenous infusion every 6 months, showed in clinical trials that it could better Merck’s older injectable treatment Rebif in patients suffering from RMS. When compared with placebo, the drug also reduced the risk of disability progression by 24% in patients with the particularly debilitating PPMS.
“Ocrevus is the first investigational medicine to significantly reduce disability progression in people with relapsing and primary progressive forms of MS,” said Dr. Sandra Horning, chief medical officer and head of global product development.
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