SRPT - Roche's Ocrevus Subcutaneous Gets European Commission Nod | Benzinga
Roche (OTC: RHHBY) announced that the European Commission has granted marketing authorization to the subcutaneous formulation of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) drug Ocrevus (ocrelizumab).
The approval is based on pivotal data from the late-stage OCARINA II trial, which showed non-inferior levels of the drug in the blood when administered subcutaneously, and a safety and efficacy profile comparable to the intravenous (IV) formulation in patients with RMS and PPMS.
The SC formulation of Ocrevus was developed to provide an alternative twice-a-year treatment option to patients and healthcare professionals, in addition to IV.
Ocrevus SC combines Ocrevus with Halozyme Therapeutics' ENHANZE drug delivery technology.
Roche also announced that the European Medicines Agency ("EMA") has validated and initiated review of the marketing authorization application for Elevidys (delandistrogene moxeparvovec).Elevidys, a gene therapy for the treatment of ambulatory patients aged 3-7 years with Duchenne muscular dystrophy, is already approved in the United States and some other countries. It is a one-time treatment administered through a single IV dose.
The MAA is based on results from the phase III EMBARK study, a global, randomized, double-blind, placebo-controlled study in DMD patients aged 4 through 7 years. Although the EMBARK study did not meet the primary endpoint, the totality of evidence from the trial confirmed that Elevidys is the first gene therapy to provide clinically ...