Drug Development

Roche’s megablockbuster MS candidate ocrelizumab posts promising head-to-head data

By most accounts, Roche’s ocrelizumab is likely the biggest drug in the industry’s late-stage pipeline, with peak revenue potential ranging up to a megablockbuster $7 billion or so. And today the company whet the appetite of analysts with a head-to-head comparison with Merck KGaA’s Rebif – already under assault from Tecfidera (Biogen), Gilenya (Novartis) and Aubagio (Sanofi) – that makes the new drug look even better.

Investigators say they were able to determine that the drug increased the proportion of relapsing/remitting MS patients seeing the elimination of disease activity by 75% over 96 weeks compared to Rebif.

Most achieved that status at the end of 24 weeks of treatment with the therapy, to be sold as Ocrevus. And the company also outlined new positive data on the elimination of disease progression among primary progressive MS patients compared to a placebo.

Once approved, which is likely, ocrelizumab could be used to treat most MS patients, a unique distinction that is likely to make this a key focus among doctors who specialize in treating MS. And that could be a game changer for everyone in the field.

Roche is looking at a final FDA marketing decision just before the end of this year, unless the FDA decides to cut to the chase with an early approval. This therapy is at the heart of Roche’s case that it can fend off looming generic competition, so the sooner it gets a green light, the better.

Professor Gavin Giovannoni at Barts and The London School of Medicine and Dentistry, who led the OPERA I and II studies, had this to say in a prepared statement:

“These new data suggest that ocrelizumab consistently impacts disease progression and has the potential to change how we approach treating both relapsing and primary progressive MS.”

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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