Roche’s ground-breaking MS drug delayed by manufacturing issues

pharmafile | December 22, 2016 | News story | |  Genentech, MS, Roche, multiple sclerosis 

Roche has released both good and bad news just before Christmas. The good news is very good news for individuals suffering from multiple sclerosis.  Genentech, a subsidiary of Roche, has revealed that Phase 3 studies of its drug, Ocrevus (ocrelizumab), for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) displayed positive results. The bad news is that the treatment has been delayed due to manufacturing issues by the FDA until 28 March at the latest.

Ocrevus will become the first treatment that has displayed positive results for the primary progressive form of the disease. The drug was also shown to be more effective than high doses of the alternative treatment for RMS. The drug was found to slow deterioration in those patients suffering from PPMS from 39% without treatment to 33% in those who were taking Ocrevus. With those patients suffering from RMS, the treatment was found to be superior in three markers of disease activity: relapses, disability progression and brain lesion activity over the two-year trial.

“Ocrevus is the first and only investigational medicine to significantly reduce the progression of physical disability in primary progressive MS in a large Phase III study,” said Xavier Montalban, chair of the Scientific Steering Committee of the ORATORIO study. “Over the last decade, other molecules have tried and failed to demonstrate efficacy for PPMS, so the positive results for Ocrevus mark an important step in our understanding of this highly disabling form of the disease.”

The drug is a promising prospect for those individuals who are suffering from MS, as it offers the strongest results in trials of any treatment. It also was displayed favourable safety profile. The snag has come when it came to review by the FDA, where the addition of further data by Roche regarding the commercial manufacturing process of the drug caused the date to be pushed back from 28 December to 28 March.

It’s only a slightly blow to Roche, who expected the drug to achieve peak sales of anywhere from $3 billion to $7 billion. However, for those patients suffering from MS, it represents lost time in their goal for treatment. The delay will likely see approval for Ocrevus achieved in both Europe and US in early 2017.

Ben Hargreaves

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