Date: 22-Apr-2020

US FDA, EMA Accept Roche’s SBLA For Ocrevus Shorter 2-hour Infusion Time To Treat MS

Roche announced that the US Food and Drug Administration (US FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and the European Medicines Agency (EMA) has validated the application for a two-hour Ocrevus (ocrelizumab) infusion time, dosed twice yearly for relapsing or primary progressive multiple sclerosis (MS).

“With more than 150,000 people treated with Ocrevus, the twice-yearly dosing schedule has benefited many MS patients and their physicians, as indicated by more than 90 percent of patients continuing with treatment through one year,” said Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of Global Product Development. “We hope a shorter infusion time will further improve the experience for people living with MS while also increasing capacity in healthcare systems.”

The regulatory applications are based on data from the randomised, double-blind ENSEMBLE PLUS study, which showed comparable frequency and severity of infusion-related reactions (IRRs) for a two-hour Ocrevus infusion time vs. the currently approved 3.5-hour time in patients with relapsing-remitting MS (RRMS). The first dose was administered per the approved dosing schedule (two 300 mg intravenous (IV) infusions separated by two weeks) and the second or later doses (600 mg IV infusion) were administered over a shorter, two-hour time. The primary endpoint of this study was the proportion of patients with IRRs following the first randomised 600 mg infusion (frequency/severity assessed during and 24-hours post infusion). No patients discontinued the study due to an IRR and no new safety signals were detected.

Detailed data will be presented at the earliest opportunity. The FDA and the European Commission are expected to make decisions on these applications by the end of 2020.

With rapidly growing real-world experience and more than 150,000 patients treated globally, Ocrevus has twice-yearly (six-monthly) dosing and is the first and only therapy approved for RMS (including relapsing-remitting MS (RRMS) and active, or relapsing, secondary progressive MS, in addition to clinically isolated syndrome in the US) and primary progressive MS (PPMS). Ocrevus is approved in 90 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland and the European Union.

Ocrevus (ocrelizumab) is the first and only therapy approved for both RMS (including RRMS and active, or relapsing, SPMS, in addition to CIS in the US) and PPMS.

Ocrevus is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage.

This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, Ocrevus binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved. Ocrevus is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.