Roche gets USFDA nod for Ocrevus Zunovo for relapsing and progressive multiple sclerosis
Basel: Roche announced that the United States Food and Drug Administration (U.S. FDA) has approved OCREVUS ZUNOVO (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS))and primary progressive multiple sclerosis (PPMS).
OCREVUS ZUNOVO is a twice-a-year, healthcare professional (HCP)-administered approximately 10-minute subcutaneous (SC) injection approved for both these forms of multiple sclerosis, giving people living with MS more treatment options.
“OCREVUS ZUNOVO gives patients and providers another option for receiving OCREVUS, building on a decade of robust safety and efficacy data for OCREVUS in multiple sclerosis,” said Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of Global Product Development. “This approval may offer greater flexibility for healthcare providers and people living with multiple sclerosis, based on their individual treatment needs.”
“People are living longer with chronic illnesses and with fewer disabilities because of the extensive progress that has been made in the development of medicines that can slow their progression,” said Natalie Blake, Executive Director of the MS Foundation. “But still, not everyone has access to these medicines. It’s crucial to acknowledge each experience with MS is as unique as the individual navigating it, so providing choices to address each person’s needs is essential. We are pleased that with a new method of delivery, there is now an additional option for those who need flexibility in the route of administration or treatment time.”
After the first dose, the time for treatment with OCREVUS ZUNOVO could be as little as 55 minutes. Patients will be required to take premedications at least 30 minutes prior to each dose. Following the first dose, patients will be monitored by their HCP for at least 60 minutes. Patients will be monitored for at least 15 minutes post-injection for subsequent doses.
The FDA approval is based on pivotal data from the Phase III OCARINA II trial, which showed no clinically significant difference in the levels of OCREVUS in the blood when administered subcutaneously, and a safety and efficacy profile consistent to the IV formulation in people with RMS and PPMS. Out of the exploratory outcomes measured, OCREVUS ZUNOVO was consistent with IV, demonstrating suppression of relapse activity (97%) and MRI lesions (97%) through 48 weeks. Additionally, one of several patient-reported outcomes measured during the study showed more than 92% of trial participants reported being satisfied or very satisfied with the SC administration of OCREVUS ZUNOVO.
In the Phase III OCARINA II trial, the safety profile of OCREVUS ZUNOVO was consistent with the well-established safety profile of OCREVUS IV, with the exception of injection reactions.
