EU approves Ocrevus for relapsing forms of multiple sclerosis and early primary progressive multiple sclerosis.

Roche announced that the European Commission (EC) has granted marketing authorisation for Ocrevus (ocrelizumab) for patients with active relapsing forms of multiple sclerosis defined by clinical or imaging features and for patients with early primary progressive multiple sclerosis in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.

Multiple sclerosis (MS) affects approximately 700,000 people in Europe, of which around 96,000 have the highly disabling primary progressive form. Most people with MS have a relapsing form (RMS) or primary progressive MS (PPMS) at diagnosis.

The EU approval is based on data from three pivotal Phase III studies from the ORCHESTRA trial programme of 2,388 patients who met primary and nearly all key secondary endpoints. Data from two identical Phase III studies in relapsing forms of MS (OPERA I and OPERA II) showed Ocrevus demonstrated superior efficacy with approximately 80 percent of patients relapse free and significantly slower progression of the disease compared with high-dose interferon beta-1a (Rebif) over the two-year controlled treatment period. Ocrevus also significantly increased the chance of a patient having no evidence of disease activity (NEDA; brain lesions, relapses and worsening of disability) by 64 percent in OPERA I and 89 percent in OPERA II compared with high-dose interferon beta-1a (p<0.0001 and p<0.0001). In a separate PPMS Phase III study (ORATORIO), Ocrevus was the first and only treatment to significantly slow disability progression and reduce signs of disease activity in the brain (MRI lesions) compared with placebo with a median follow-up of three years. Patients treated with Ocrevus were 24 percent less likely to have disability progression for three months and 25 percent less likely to have disability progression for six months (p=0.0321 and p=0.0365, respectively). Ocrevus also significantly slowed the progression of walking impairment by 29.4 percent, measured by the timed 25-foot walk, compared with placebo (p=0.0404).

Comment: There are currently no approved treatments for PPMS, a debilitating form of MS characterized by steadily worsening symptoms and typically without distinct relapses or periods of remission.