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Novartis scores promising phase 3 MS study

Takes fight to Roche’s blockbuster ocrevus

Swiss drugmaker Novartis’ multiple sclerosis (MS) drug ofatumumab (OMB157) has met the primary and key secondary endpoints to reduce the annualised relapse rate of the progressive disease.

The drug demonstrated superiority over Sanofi’s approved MS treatment teriflunomide (aubagio) in patients with relapsing forms of MS. The results came from Novartis’ ASCLEPIOS I and II studies, and in both studies ofatumumab showed a reduction in the number of confirmed relapses. The key secondary endpoints, which included delaying time to confirmed disability progression, were also met in both head-to-head studies.

The drug is already approved for the treatment of chronic lymphocytic leukemia (CLL), but if Novartis can gain approval for ofatumumab in MS, sales are likely to expand exponentially.  The positive data results from this round of phase 3 studies comes on the heels of an FDA approval earlier this year for Novartis’ Mayzent, which is specifically approved for patients with active secondary progressive multiple sclerosis (SPMS).

It seems that Novartis is continuing to stake a claim in the MS therapy area, but will have to battle hard with competitors, including Roche’s blockbuster MS drug ocrevus. Roche’s drug has had a strong uptake in both relapsing-remitting and primary progressive forms of MS in the US, and made $2.4bn in 2018. Ocrevus is also the only drug approved for the treatment of primary progressive MS, so will be a tough competitor for Novartis to take on.

Both ocrevus and ofatumumab selectively target the immune system’s CD20-positive B cells that damage nerve tissue and cause disease progression – this could potentially set a head-to-head fight between the two treatments if ofatumumab is eventually approved. However, the studies have not compared ofatumumab to ocervus, and Sanofi’s teriflunomide makes up a smaller percentage ($1.84bn) of the market share for MS than Roche’s drug.

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John Tsia, head of global drug development and chief medical officer, Novartis

“Ofatumumab, if approved, could be a highly attractive treatment option for a broad RMS patient population, including early MS,” said John Tsai, head global drug development and chief medical officer, Novartis.

“The powerful study results are a reflection of our commitment to reimagine MS treatment at all stages of the disease,” he added.

The detailed results from the ASCLEPIOS studies are due to be presented at an MS conference in Stockholm, Sweden next month. Novartis has plans to start filing ofatumumab with health authorities for approval of the drug by the end of the year.

Article by
Lucy Parsons

30th August 2019

From: Research



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