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Roche Gets Breakthrough Therapy Designation From FDA for Multiple Sclerosis Treatment

Decision will likely speed up introduction of what is expected to be a blockbuster drug

JOHN REVILL

Feb. 17, 2016 9:48 a.m. ET

ZURICH— Roche Holding AG said it has received breakthrough therapy designation from the U.S. Food and Drug Administration for a new multiple sclerosis treatment, likely speeding up the introduction of what is predicted to be a blockbuster drug.

The decision means ocrelizumab, for use in the treatment of people with primary progressive multiple sclerosis, or PPMS, could get market authorization in six to seven months instead of the usual 10 to 12 months.

If positively assessed, ocrelizumab could go on sale in the second half of 2016. Analysts estimate it could eventually have sales potential of at least $1.5 billion.

Roche Profit Dented by Strong Swiss Franc (Jan. 28)

“This 12th breakthrough designation in Roche’s portfolio, one of the highest rates in the industry, once more highlights the exceptional innovation rate at Roche,” saidBruno Bulic, an analyst at Baader Helvea.

Basel-based Roche said there are no approved treatments for PPMS, a debilitating form of MS characterized by steadily worsening symptoms and typically without distinct relapses or periods of remission.

Multiple sclerosis affects an estimated 2.3 million people around the world and there is currently no cure. The disease occurs when the immune system attacks the insulation around nerve cells in the brain, spinal cord and optic nerves.

Damage to these nerves can cause symptoms that include muscle weakness, fatigue and difficulty seeing. A phase III trial of ocrelizumab presented last year showed the treatment “significantly reduced disability progression,” Roche said.

The Swiss pharmaceuticals giant said it plans to pursue marketing authorization for the treatment of both PPMS and relapsing multiple sclerosis, a more common form of the disease, and will submit data from three pivotal phase III studies to global regulatory authorities in the first half of 2016.

“With no approved treatments for primary progressive MS, ocrelizumab has the potential to address an important unmet need,” said Sandra Horning,Roche’s chief medical officer and head of global product development. “We are committed to working with the FDA to bring ocrelizumab to people with primary progressive MS as quickly as possible.”

Write to John Revill at john.revill@wsj.com

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jim LIBERTYFeb 18, 2016

This is truly great news for the MS community. Finally there's treatment for those with progressive MS. Bring it on the market ASAP!!!

james wrightFeb 17, 2016

God Bless the scientists at Roche.

james wrightFeb 17, 2016

I bet the evil people at Roche are seeking to generate profits by conducting drug research and development. I'm going to vote for Hillary, she'll put a stop to this sort of conduct.

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