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Roche’s Ocrevus is first primary progressive MS drug in EU

Analysts predict the drug could be a $3bn product by 2021


Roche’s CD20-targeting antibody Ocrevus has become the first and only drug to be approved in the EU for the primary progressive for of multiple sclerosis (PPMS).

The new drug has also been cleared for relapsing forms of MS by the European Commission, covering the two most common types of a disease which affects some 700,000 people in Europe. There are an estimated 96,000 Europeans with PPMS, a highly-disabling early-onset form of the disease in which there is no relapsing/remitting stage.

Until now, patients suffering from PPMS have had to rely on drugs that try to manage symptoms and as well as rehabilitation therapy as drugs for relapsing forms such as beta interferons and Teva’s Copaxone (glatiramer acetate), as well as new oral therapies such as Novartis’ Gilenya (fingolimod), have shown little benefit.

In the ORATORIO study, Ocrevus was able to slow disability progression by around 24% in PPMS patients, and reduce signs of disease activity in the brain (MRI lesions) compared with placebo, with a median follow-up of three years.

Ocrevus was also the first drug to be approved in the US for PPMS in March 2017, and despite increasing competition in the broader MS market the new indication is expected to catapult the drug to blockbuster status quickly. It had already garnered around $500m in sales in the first nine months of 2017 and could become a $3bn product by 2021, according to consensus analyst data compiled by Reuters.

One reason for the rapid take-up is clinical data showing that Ocrevus is more effective in relapsing MS than Merck KGaA’s beta interferon drug Rebif, as well as competitive pricing; in the US it launched at a price ($65,000 per year before discounts) that undercut its clinical rival by around a quarter.

The UK MS Society’s director of external affairs, Genevieve Edwards, hailed the approval as a “significant day” for people with PPMS … who have never had an effective treatment.

Nevertheless, the charity points out that the EU license means the drug can only be prescribed for people with early PPMS, i.e. those who have evidence of inflammatory activity identified through an MRI scan, while the length of time living with MS symptoms and the level of disability will also be taken into account when making prescribing decisions.

“Limitations on who can use ocrelizumab will be disappointing to some people with progressive forms of the condition, who still don’t have treatment options [but] this is an important step towards effective medicine for everyone with MS,” said Edwards.

“The next challenge is making ocrelizumab available on the NHS,” she added. “We urge the manufacturer and appraisal bodies across the UK to make that happen as soon as possible, recognising the critical unmet need for treatment for thousands living with the condition.”

Article by
Phil Taylor

12th January 2018

From: Regulatory



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