Positive Phase III results for Roche’s OCREVUS (ocrelizumab) twice a year, 10-minute subcutaneous injection in patients with multiple sclerosis
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III OCARINA II trial evaluating OCREVUS® (ocrelizumab) as a twice a year 10-minute subcutaneous injection met its primary and secondary endpoints in patients with relapsing forms of MS or primary progressive MS (RMS or PPMS). OCREVUS subcutaneous injection was shown to be non-inferior to OCREVUS given by intravenous infusion (IV), as measured by pharmacokinetics (levels in the blood) over 12 weeks. OCREVUS subcutaneous injection was also comparable with OCREVUS IV in controlling magnetic resonance imaging (MRI) lesion activity in the brain over 12 weeks. The safety profile of OCREVUS subcutaneous injection was consistent with that of OCREVUS IV.
The OCREVUS 10-minute injection is designed to be administered without the need for IV infrastructure so it has the potential to expand the usage of OCREVUS in MS centres without IV infrastructure or those with IV capacity limitations. It also retains the twice-yearly dosing regimen of OCREVUS IV that has shown high persistence and adherence since becoming a standard of care MS treatment.1 This provides an additional delivery option so that the administration of OCREVUS can be matched to the individual needs of patients and healthcare professionals.
“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., Roche’s Chief Medical Officer and Head of Global Product Development. “This new subcutaneous injection will allow OCREVUS to be administered in 10 minutes twice a year, helping people living with MS to spend less time in treatment for this disease.’’
Detailed results from the trial will be presented at an upcoming medical meeting and submitted to health authorities around the world. Roche is committed to advancing innovative clinical research programmes to broaden the scientific understanding of MS, further reduce disability progression in RMS and PPMS and improve the treatment experiences for those living with the disease.