Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved OCREVUS ZUNOVO™ (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This new formulation is the first and only twice-a-year subcutaneous (SC) injection, administered by a healthcare professional in approximately 10 minutes, approved for both forms of MS, offering more treatment flexibility for patients.
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, commented, “OCREVUS ZUNOVO provides patients and healthcare providers with an additional option for administering OCREVUS, building on a decade of safety and efficacy data. This approval may offer greater flexibility based on individual treatment needs.”
Natalie Blake, Executive Director of the MS Foundation, emphasized the importance of personalized care, stating, “While progress in medicine has enabled people to live longer with chronic illnesses and reduced disabilities, access to these treatments remains uneven. With this new delivery option, individuals can have more flexibility in their treatment choices.”
OCREVUS ZUNOVO offers a faster treatment time following the first dose, potentially as short as 55 minutes. Patients will need to take premedications at least 30 minutes before each dose, with monitoring for at least 60 minutes for the first dose and 15 minutes after subsequent doses.
The FDA approval was based on results from the Phase III OCARINA II trial, which showed that OCREVUS administered subcutaneously had no clinically significant difference in blood levels compared to the intravenous (IV) form. The safety and efficacy profiles were consistent across both formulations, with relapse suppression and MRI lesion reduction rates of 97% over 48 weeks. Additionally, more than 92% of trial participants reported satisfaction with the SC administration method.
The safety profile of OCREVUS ZUNOVO was generally similar to that of the IV version, except for injection reactions, which occurred more frequently with the first injection. About 49% of participants reported mild or moderate injection reactions, none of which led to treatment discontinuation.
Roche remains committed to advancing clinical research in MS, with over 30 ongoing trials aimed at better understanding the disease and improving treatment experiences. The development of new formulations, such as OCREVUS ZUNOVO, is part of Roche’s broader effort to enhance patient experiences and offer a variety of treatment options tailored to individual needs.
