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Roche's MS drug Ocrevus awarded priority review by FDA

Comes as Swiss company files the therapy with the FDA and EMA

Roche's multiple sclerosis treatment Ocrevus (ocrelizumab) will undergo a fast-tracked appraisal process in the US after winning priority review status from the FDA.

The designation could shave months off the drug's assessment process with a ruling expected by 28 December this year, and it and comes as Ocrevus is filed in both the US and Europe.

Roche is seeking a licence for the drug to treat both forms of MS - relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) -which respond poorly to current therapies.

Ocrevus is the first investigational medicine with the potential to treat both forms, outperforming Merck's Rebif in phase II trials.

Roche's MS antibody selectively targets CD20-positive B cells, a type of immune cell believed to contribute to the destruction of myelin and axonal nerve cells, the key feature of MS disease activity.

In the Opera I and II clinical trials for RMS, Ocrevus reduced annual relapse rates and the progression of clinical disability when compared with Rebif, as well as having greater efficacy in reducing the number of MS lesions in the brain.

The study of Ocrevus' effect on people with PPMS, Oratorio, also showed 'significant' reductions in disability progression and other markers of disease activity.

Sandra Horning, chief medical officer and head of global product development at Roche, said that the firm is “pleased by the FDA's decision to classify their review of the BLA as priority because we believe Ocrevus has the potential to help people living with either of the two forms of MS”.

She added: “We will continue to work closely with the FDA and EMA to bring this investigational medicine to people with MS as quickly as possible.”

A report published by Decision Resources in 2014 suggested that Ocrevus could become the treatment of choice for advanced-stage MS patients, adding that an effective drug for the PPMS patient population alone could become a blockbuster product.

If approved Ocrevus will compete for MS market share with Biogen's recently-approved Zinbryta, while Novartis has an anti-B cell candidate in its pipeline, which the company claims has the potential to become “best-in-class”.

Article by
Rebecca Clifford

29th June 2016

From: Regulatory



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