FDA to Review Data on Shorter Infusion Time for MS Drug Ocrevus

The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for a 2-hour Ocrevus (ocrelizumab; Genentech) infusion time, shortening the conventional infusion duration for patients with relapsing or primary progressive multiple sclerosis (MS).

The sBLA includes data from the randomized, double-blind phase 3b ENSEMBLE PLUS study that compared the frequency and severity of infusion-related reactions for a 2-hour Ocrevus infusion time to the currently approved 3.5-hour infusion time in patients with relapsing-remitting MS. Patients received the approved initial dosing schedule of two 300mg intravenous (IV) infusions separated by 2 weeks followed by subsequent doses of 600mg IV infusion over a shorter 2-hour time every 6 months. The primary end point was the proportion of patients with infusion-related reactions following the first randomized 600mg infusion; frequency and severity were assessed during and for 24 hours after the infusion.

Preliminary data showed that there were no discontinuations due to infusion-related reactions and no new safety signals were detected. 

The FDA is expected to make a decision on the application by the end of 2020.

Ocrevus, a CD20-directed cytolytic antibody, is currently approved for the treatment of adult patients with relapsing or primary progressive MS. The treatment has been associated with infusion reactions such as pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, tachycardia, and anaphylaxis. Across multiple trials, the incidence of infusion reactions in treated patients was observed to be 34-40% with the highest incidence linked to the first infusion. To reduce the frequency and severity of infusion reactions, it is recommended that patients be premedicated with methylprednisolone and an antihistamine; an antipyretic may also be considered.

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