Roche’s Multiple Sclerosis Drug Under Review by FDA, EMA

Roche Holding RHHBY announced that the FDA has accepted its Biologics License Application (BLA) for Ocrevus (ocrelizumab) for review as the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

The BLA was also granted Priority Review Designation with a targeted action date of Dec 28, 2016.

Additionally, the EMA has validated Roche’s Marketing Authorization Application (MAA) for Ocrevus.

We note that Priority Review Designation is granted to medicines that the FDA believes to have the potential for significant improvements in safety and effectiveness of a treatment of a serious disease.

Earlier in 2016, the FDA had granted Breakthrough Therapy designation to Ocrevus for the treatment of PPMS.

We note that Roche is evaluating Ocrevus in a phase III development program – OPERA I, OPERA II and ORATORIO. While OPERA I and OPERA II are identical phase III, randomized, global multi-center studies that are evaluating the efficacy and safety of Ocrevus (600 mg administered by intravenous infusion every six months) versus interferon beta-1a (44 mcg administered by subcutaneous injection three times per week) for the treatment of relapsing forms of MS (relapsing-remitting MS and secondary progressive MS with relapses).

Meanwhile, the randomized phase III study, ORATORIO, is evaluating the efficacy and safety of Ocrevus (600 mg administered by intravenous infusion every six months) as compared to placebo in patients with PPMS.

We are impressed by the company's efforts to grow its portfolio beyond oncology and foray into new avenues such as MS and asthma. Roche currently has more than a dozen pipeline candidates for diseases that include MS, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease, Down syndrome and autism.

The company currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Pfizer, Inc. PFE, Bristol-Myers Squibb Co. BMY and Johnson & Johnson JNJ. While Pfizer and Bristol-Myers sport a Zacks Rank #1 (Strong Buy), Johnson & Johnson is a Zacks Rank #2 (Buy) stock.

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