Subcutaneous Ocrevus approved in EU for relapsing MS, PPMS

The European Commission has approved a subcutaneous, or under-the-skin, formulation of Ocrevus (ocrelizumab) to treat adults with multiple sclerosis (MS).

The approval makes the new formulation available in the European Union for the same indications as the original intravenous (into-the-vein) formulation, which is available to people with relapsing forms of MS with active disease — as defined by certain clinical or imaging features — as well as primary progressive MS (PPMS). 

The decision, which follows the recommendation for approval from an advisory committee of the European Medicines Agency (EMA), brings an easier-to-administer formulation of the CD20 inhibitor to MS patients in Europe.

While the original Ocrevus formulation is given via a two- to four-hour infusion, the newly approved version can be given via an under-the-skin injection that takes 10 minutes.

“Ocrevus transformed the way multiple sclerosis is treated as the first anti-CD20 therapy approved in this disease,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, said in a press release. “Now, people in the EU with multiple sclerosis can have their medicine administered in just 10 minutes twice per year without needing an [intravenous] facility.”

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Patient-friendly treatment

The approval makes subcutaneous Ocrevus the first therapy approved to treat people with relapsing forms of MS and PPMS with a patient-friendly, 10-minute injection, twice a year.

“This makes it easier for more people with multiple sclerosis to access their treatment, while also saving time for providers,” Garraway said.

Ocrevus is an antibody-based medication that blocks the CD20 protein found at the surface of B-cells, a type of immune cell that contributes to MS-driving inflammation, reducing their number. The treatment is designed to decrease disease activity and slow disability progression.

The therapy’s intravenous formulation is approved in the U.S. and Europe to treat relapsing forms of MS and PPMS. However, some patients may have difficulties accessing infusion facilities, and some centers have limited capacity to deliver infusion medications.

To address those difficulties and reduce the time needed to administer Ocrevus, the company developed a subcutaneous formulation that allows for faster administration. This version still has to be given by a healthcare professional, but it can be done outside the clinic.

The new formulation was tested in the Phase 3 OCARINA II trial (NCT05232825), which compared its safety, efficacy, and pharmacological properties to those of intravenous Ocrevus in 236 adults with relapsing forms of MS and PPMS.

Participants were randomly assigned to receive either an initial 920 mg dose of the subcutaneous formulation or the approved 600 mg dose, given in two intravenous infusions two weeks apart. The first dose of intravenous Ocrevus is given before the every six-month dosing.

After a follow-up period of 24 weeks (about six months), all patients then received the subcutaneous formulation every six months for up to about two years.

The trial’s results indicated that both formulations were well tolerated, with no new safety concerns, and resulted in similar reductions in B-cells within a couple of weeks after treatment initiation. After one year, the majority of patients on either formulation were free from relapses, and most had no inflammatory lesions or new or enlarging lesions.

More than 92% of patients who responded to a survey reported being satisfied or very satisfied with the new formulation.

Roche also has filed for the approval of subcutaneous Ocrevus in the U.S. A decision is expected in September.