FDA Approves Subcutaneous Ocrevus, Expanding Access to Roche and Genentech Blockbuster

The FDA has given the green light to a new formulation of Roche and Genentech's multiple sclerosis (MS) drug, Ocrevus, which they anticipate will significantly enhance patient access. The updated version, branded as Ocrevus Zunovo, allows for 10-minute subcutaneous injections instead of the hours-long intravenous (IV) infusions that were previously required. Although still administered by healthcare professionals, this new method eliminates the need for patients to make lengthy trips to specialized infusion centers, a change expected to facilitate easier treatment adherence.

According to a Genentech spokesperson, Ocrevus Zunovo will have a pricing structure aligned with the annual wholesale acquisition cost of the previous infusion form. Initially priced at approximately $65,000 per year upon its approval in 2017, the cost has climbed to around $80,000 annually.

The approval of this new formulation was based on compelling data from the Phase 3 OCARINA II trial. The study demonstrated that the effectiveness of Ocrevus Zunovo, administered as twice-yearly injections, was comparable to the IV formulation. It showed a 97% suppression rate of MS relapse and a 97.2% reduction in MRI-detected brain lesions after 48 weeks. The trial included patients with both relapsing and primary progressive forms of MS, the same conditions the IV version of Ocrevus treats.

In 2023, Ocrevus emerged as Roche’s top-selling drug, generating approximately $7.5 billion in global sales. For the first half of this year alone, sales approached $4 billion.

The shift from IV to subcutaneous administration follows a common industry practice where infusion treatments are eventually adapted to more convenient delivery methods. David Jones, the principal medical director of MS at Genentech, explained that initial drug formulations are often in infusion form because they are easier to administer directly into the bloodstream.

Jones emphasized that access is a critical issue for MS patients. Recalling his days as a practicing physician at the University of Virginia, he noted that some patients would drive four to five hours just to receive their infusions. He highlighted that many infusion centers were extremely busy, leading to long wait times, and taking a day off work for treatment was particularly burdensome for patients from Appalachia.

In sum, the FDA's approval of Ocrevus Zunovo marks a significant advancement in the treatment of multiple sclerosis. By offering a quicker and more accessible method of administration, the new subcutaneous injections are set to make a substantial difference in the lives of MS patients, potentially increasing adherence to treatment and improving overall quality of life.