US FDA delays Ocrevus decision date asking Roche for more manufacturing data

By Gareth Macdonald contact

- Last updated on GMT

The US FDA has pushed back the review date Roche’s Ocrevus (ocrelizumab) after asking for more data on processes used to manufacture the candidate MS treatment.

Roche announced the US regulator had extended the PDUFA date on Tuesday​, explaining the agency will now decide whether to approve Ocrevus on March 28.

The Swiss firm said the extension was “the result of the submission of additional data by Roche regarding the commercial manufacturing process of Ocrevus, which required additional time for FDA review​.”

Ocrevus is being developed for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

It was accepted for review by the US Food and Drug Administration (FDA) in June.

The agency earmarked Ocrevus for “priority review,” meaning it would decide whether to approve the drug in six months rather than the usual 12.

Priority review status is granted to drugs that have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. 

In addition, the FDA designated Ocrevus as a “breakthrough therapy” for the treatment of PPMS in February.

Roche did not respond to a request for comment.

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