Europeans with relapsing multiple sclerosis (MS) and early primary progressive MS (PPMS) are one step closer to accessing Ocrevus (ocrelizumab), now that the European Medicines Agency (EMA) has urged the European Union to approve the therapy.
The positive opinion — announced in a press release issued Nov. 10 by the EMA’s Committee for Medicinal Products for Human Use (CHMP) — is an intermediary step required in the regulatory pathway to allow patient access to a new drug. The European Commission will now make a final decision on whether Ocrevus should be granted marketing authorization in all 28 EU member states. This decision will take the CHMP recommendation into consideration.
If approved, Ocrevus will become the first disease-modifying medicine available throughout Europe for patients with PPMS. Once this happens, any decisions on price or insurance reimbursements will be the responsibility of each member state.
Ocrevus is an anti-CD20 antibody developed by Genentech, a division of Roche. It blocks immune B-cells, preventing them from attacking nerve cells and their myelin protective sheath, as well as inhibiting other pro-inflammatory immune signals involved in MS.
CHMP based its positive recommendation on data from three pivotal Phase 3 clinical trials: the OPERA I and II trials (NCT01247324 and NCT01412333) in relapsing MS patients, and the ORATORIO trial (NCT01194570) in PPMS patients.
Results from the OPERA clinical studies demonstrated that treatment with Ocrevus for up to 96 weeks could reduce the annualized relapse rate by 46.4 percent compared with EMD Serono’s approved drug Rebif (interferon beta-1a) in relapsing MS patients.
The ORATORIO trial showed that Ocrevus could reduce by 24 percent the risk of 12-week confirmed disability progression compared to placebo in PPMS patients. Data from the trial further supported the drug’s therapeutic benefit in early-stage PPMS patients. Additional studies are warranted to better evaluate the therapeutic potential of Ocrevus for patients with more advanced stages of the disease.
The most common treatment-associated adverse effects reported were infusion-related reactions and infections.