The FDA on Friday approved a new formulation of Roche and Genentech’s multiple sclerosis drug Ocrevus in what they hope will broadly expand access to the treatment.
Patients will now be able to take Ocrevus through 10-minute subcutaneous injections rather than hours-long infusions. The drug, to be sold as Ocrevus Zunovo, will still be administered by physicians but won’t require long trips to specialized infusion centers, which the companies hope will make it easier for patients.
Ocrevus Zunovo will be priced “at parity” with the infusion form’s annual wholesale acquisition cost, a Genentech spokesperson said. Ocrevus was priced at about $65,000 per year when it was first approved in 2017, but the cost has risen to roughly $80,000 annually.
Regulators approved the new formulation based on data from the Phase 3 OCARINA II trial, which showed non-inferiority, and that twice-a-year injections of Ocrevus Zunovo suppressed MS relapse by 97% and reduced MRI lesions in the brain by 97.2% after 48 weeks. The trial enrolled patients with both relapsing and primary progressive MS, which IV Ocrevus is approved to treat.
Ocrevus was Roche’s top-selling drug in 2023, pulling in about $7.5 billion in worldwide sales. In the first half of this year, its sales came in at just under $4 billion.
The strategy follows the well-established model of IV infusion treatments eventually being updated with subcutaneous formulations. Generally, drugmakers try to develop infusion therapies first because it’s easier to get into the bloodstream, David Jones, the principal medical director of MS at Genentech, told Endpoints News.
Access is very important to MS patients, Jones added. He said that when he used to be a practicing physician at the University of Virginia, some patients used to drive four to five hours for their infusion appointments.
“Many infusion centers are fairly active, sometimes the wait times were long,” Jones said. “And sometimes, as you can imagine, for the western part of the state being Appalachia, taking a day off work was really challenging.”
Editor’s note: This article has been updated to correct the brand name of subcutaneous Ocrevus. It is Ocrevus Zunovo, not Ocrevus Zyntulo.