The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of ocrelizumab (Ocrevus, Roche) for adults with relapsing multiple sclerosis (RMS) and early primary progressive multiple sclerosis (PPMS).
Ocrelizumab “provides an additional treatment option for patients with RMS and is the first medicine in the EU [European Union] intended to treat some patients with PPMS,” the EMA said in a news release. “There are currently no disease-modifying therapies available for this particular form of MS so there is a great medical need for treatment of such a relentless, seriously debilitating disease.
Ocrelizumab is a humanized anti-CD20 monoclonal antibody that selectively targets CD20-expressing B cells. It will be available as a 300-mg concentrate for solution for infusion.
The CHMP’s positive opinion stems from three phase 3 clinical trials in 1423 patients with MS: two in patients with RMS and one in patients with PPMS.
In patients with RMS, treatment with ocrelizumab significantly reduced the annualized relapse rate by 46.4% at 96 weeks compared with interferon β-1a. In patients with PPMS, treatment with ocrelizumab led to a 24% reduction in the risk for 12-week confirmed disability progression compared with placebo. Data from the clinical trial in PPMS suggest that patients in the early stage of disease benefit more from the drug.
The most common adverse reactions observed with ocrelizumab are infusion-related reactions and infections. The CHMP advises that ocrelizumab treatment be initiated and supervised by an experienced healthcare professional with access to appropriate medical support to manage severe reactions.
The CHMP’s opinion is an intermediary step to approval. The committee’s opinion will go to the European Commission for a decision on whether to grant European Union–wide marketing authorization. Once authorization is granted, each member state will decide on price and reimbursement after considering “the potential role/use of this medicine in the context of the national health system of that country,” the EMA explained in the news release.
The US Food and Drug Administration approved ocrelizumab for RMS and PPMS in March.
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