Roche's MS blockbuster Ocrevus, facing new Novartis competition, scores FDA nod for more-convenient infusion

Roche's multiple sclerosis drug Ocrevus has been approved for a two-hour infusion time, down from the existing 3.5-hour time. (Roche)

As Novartis launches its self-administered multiple sclerosis drug Kesimpta, rival Roche has been looking for a convenience boost with its earlier-to-market blockbuster Ocrevus—and it just snagged a U.S. go-ahead toward that goal.

The FDA approved a two-hour infusion time for Ocrevus, a reduction from the existing 3.5 hours, Roche said Monday. The shorter infusion was cleared by the European Medicines Agency in May.

“[W]e believe people with relapsing and primary progressive MS will find the shorter two-hour Ocrevus infusion time to be more convenient,” Roche’s Chief Medical Officer Levi Garraway said in a statement.

The approval was based on data from the Ensemble Plus trial, which aimed to test whether faster infusion would cause more infusion reactions. Turns out, the rate of reactions was comparable between the two dosing options, with 24.6% and 23.1% for 3.5-hour and 2-hour, respectively. More than 98% of the reactions resolved in both groups without complications.

Both Kesimpta and Ocrevus target CD20-positive B cells, which are believed to play a key role in MS inflammation.

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Patients can self-administer Kesimpta at home through an autoinjector, with three initial injections one week apart and monthly doses after that. In comparison, Ocrevus is infused by a healthcare practitioner every six months after an initial dose split into two infusions, two weeks apart.

An SVB Leerink survey of five MS physicians last year showed that the doctors like Kesimpta’s convenience of self-administration, as well as its “Ocrevus-like” efficacy.

Since its approval in August, Kesimpta has captured 5.2% of new-to-brand share in just 10 weeks, which put it on a similar launch trajectory with other multibillion-dollar MS drugs, Novartis CEO Vas Narasimhan said during an investor event three weeks ago. The drug has secured reimbursement for first-line use with nearly 50% of U.S. commercial lives, he added.  

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As for Ocrevus, despite a temporary COVID-related dip, the drug has charted market share between 40% and 45% for new and switch patients, Roche’s pharma chief Bill Anderson said during the company’s third-quarter earnings call in October.

“Competitive discussion aside, I think the fact is that the anti-CD20 pathway is an excellent choice for treating MS,” Anderson said. “So I wouldn’t be surprised to see Ocrevus growing at the same time that another anti-CD20 therapy could grow.”

Having said that, Roche is still pushing ahead with its clinical development work aimed at maximizing Ocrevus’ treatment potential. The Swiss drugmaker recently kicked off a phase 3b trial testing a higher dose of Ocrevus on reducing disability progression in relapsing MS and primary progressive MS.