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29 March 2024

Drug for hard-to-treat sclerosis

Published
By Agencies

Switzerland's Roche said on Monday its experimental drug ocrelizumab had proved effective against hard-to-treat primary progressive multiple sclerosis in a keenly awaited final-stage clinical trial.

The injectable antibody medicine is the first product to show positive study results in both the progressive form of the disease and more common relapsing forms, underscoring its multibillion-dollar sales potential.

Chief Executive Severin Schwan had told Reuters in an interview earlier this month that the drug's success in relapsing MS already made it a "huge opportunity" and a positive result in primary progressive multiple sclerosis (PPMS) would be "pure upside".

The drugmaker now plans to submit data to global regulatory authorities for approval of ocrelizumab in treating both forms of multiple sclerosis in early 2016, implying it could reach the market around a year later.

Results from a pivotal Phase III study of the drug in PPMS showed that treatment with ocrelizumab significantly reduced the progression of clinical disability and the effect was sustained for at least 12 weeks.

The incidence of serious adverse events associated with ocrelizumab, including serious infections, was also similar to placebo.

Safety is crucial to success. Because MS is caused by abnormal immune system attacks on the protective sheath surrounding nerve cells, treatments need to adjust the body's immune response, which can lead to dangerous side effects.

Preliminary data from the clinical trial will be presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis on Oct. 10.

Shares in Roche gained 2.5 per cent by 0715 GMT, also buoyed by encouraging results reported at the weekend for its new immune-system boosting drug atezolizumab in lung and bladder cancer, that the company hopes will help it win quick regulatory approval.