Ocrevus

Ocrevus (ocrelizumab) is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features, and for adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity. The intravenous formulation of Ocrevus was approved in the USA on 28 March 2017 and in the EU on 8 January 2018, and is approved in over 100 countries. The Marketing Authorization Application was submitted on 25 April 2016.

Key efficacy findings include a 46.4% reduction in Annualized Relapse Rate (ARR). Risk reduction in 12-week Confirmed Disability Progression (CDP) was 40% and 37%, and for 24-week CDP, it was 40% and 37%. There was a 94.9% relative reduction in the total number of T1-Gd enhancing lesions. The improvement in MSFC score change from baseline was 0.107. For a 920 mg subcutaneous dose, the predicted mean Cmax was 132 µg/mL, predicted tmax was 4 days, and predicted AUCtau was 3730 µg/mL×day.

Regarding safety, the incidence of treatment-emergent ADAs to ocrelizumab was 0%. The incidence of treatment-emergent anti-rHuPH20 antibodies was 1.1% and 4.4%. No treatment-emergent ADAs to ocrelizumab or rHuPH20 were observed. The CHMP provided a favourable recommendation for the marketing authorization extension.