Roche’s new multiple sclerosis drug set for early FDA approval

Roche’s ($RHHBY) 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.

“We are pleased by the FDA’s decision to classify their review of the BLA as priority because we believe Ocrevus has the potential to help people living with either of these two forms of MS. We will continue to work closely with the FDA and EMA to bring this investigational medicine to people with MS as quickly as possible.”

The drug is also on track for a European approval for the middle of next year. Sales for the treatment, which would for the first time be able to cover 95% of all MS sufferers, are expected to hit anywhere from $3 billion to as much as $7 billion at peak, depending on the optimism of the analyst you speak to. Roche will need it to, as the company will soon start to face the threat of biosimilars to its aging blockbuster cancer drugs.

But it may face some competition from a small, private French biotech called MedDay, which is currently testing its PPMS drug candidate MD1003 in Phase III. The company is hoping for a 2017 European approval, with an FDA filing a little further down the road.

PPMS can in fact be further divided into active or not-active progressive disease based on the existence or not of superimposed inflammatory activity--this represents the most difficult-to-treat population, and is the subpopulation MedDay is targeting with MD1003.

The biotech’s drug has hit some snags in testing, but the company is still confident of its efficacy, and earlier this year raised nearly $40 million toward its goal of approval.

- check out the release

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