Roche's new subcutaneous version measures up to IV Ocrevus in multiple sclerosis

With the multiple sclerosis market growing rapidly—from $18.9 billion in 2020 to a projected $29.8 billion in 2030, according to GlobalData—Roche is primed to take advantage with Ocrevus (ocrelizumab).

Now the monoclonal antibody, which racked (PDF) up nearly $7 billion in sales last year, appears on the verge of gaining an added advantage with a more convenient way to be administered.

A phase 3 study has shown that a new, subcutaneous version of Ocrevus has proven to be non-inferior to the current infused treatment as measured by the level of drug in the blood, 12 weeks after administration.

Specific numbers were not included in Roche’s release but the company said that the trial achieved both its primary and secondary endpoints. The injected version also matched the performance of the infused treatment in controlling magnetic resonance imaging (MRI) lesion activity in the brain over 12 weeks, Roche said.

The injected regimen of Ocrevus is a 10-minute procedure as opposed to a four-hour infusion. Both treatments are administered every six months. In addition to the time convenience, there also can be a travel edge for patients as more MS centers would be able to administer injected Ocrevus. Some MS centers are unable to deliver the infused treatment because specialized infrastructure is needed. Another limitation at some centers is IV capacity, Roche explained.

“These results give people living with MS the possibility to receive the transformational benefits of Ocrevus in the way best suited to their lives while freeing up time and healthcare resources,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of global product development.

Full results from the trial will be presented at an upcoming medical meeting and submitted to health authorities around the word, Roche added in a statement. 

Ocrevus was approved by the FDA in 2017 and in its first full year on the market brought in blockbuste sales. The treatment is given as two 300 mg infusions two weeks apart, followed by 600 mg infusions twice a year.

In 2018, the company paid $25 million plus up to $165 million in potential milestones to Halozyme Therapeutics’ in a licensing deal for the company’s Enhanze technology. Enhanze enables subcutaneous delivery of co-administered therapeutics, using a human hyaluronidase PH20 enzyme to increase tissue permeability.

Novartis is challenging Roche with its MS treatment Kesimpta, which is injected monthly after three initial starter doses. It was approved by the FDA in 2020 and generated $1.1 billion in sales in 2022.