• Reduces infusion time to 2 hours from the conventional 3.5 hours for patients with relapsing or primary progressive multiple sclerosis
• EMA approval based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional OCREVUS dosing regimen
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced European Medicines Agency (EMA) approval of a new, shorter two-hour OCREVUS® (ocrelizumab) infusion time, dosed twice yearly, for relapsing or primary progressive multiple sclerosis (MS). The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).
“The approval of a shorter, two-hour infusion time for OCREVUS in Europe, dosed twice yearly, will further improve the treatment experience for patients while also increasing capacity in healthcare systems,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “With more than 160,000 people treated with OCREVUS globally, a shorter infusion may assist both patients and healthcare providers to reach the ultimate goal of slowing disease progression in MS.’’
The approval is 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 conventional 3.5-hour time in patients with relapsing-remitting MS (RRMS) (289 patients shorter infusion; 291 conventional infusion). 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). The frequency of IRRs was comparable between those who received the two-hour infusion (24.6%) and those who received the 3.5-hour infusion (23.1%). The majority of IRRs were mild or moderate, and more than 98% resolved in both groups without complication. No IRRs were life-threatening, serious or fatal. No patients discontinued the study due to an IRR and no new safety signals were detected.
As previously communicated, the U.S. Food and Drug Administration accepted a supplemental Biologics License Application for a two-hour OCREVUS infusion time and is expected to make a decision by 14 December 2020.
With rapidly growing real-world experience and more than 160,000 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 U.S.) 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.
About OCREVUS® (ocrelizumab)
OCREVUS is the first and only therapy approved for both RMS (including RRMS and active, or relapsing, SPMS, in addition to CIS in the U.S.) 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.
About Roche in multiple sclerosis
Roche is following the science in an effort to ultimately stop disease progression and preserve function in people living with multiple sclerosis (MS). As a company, we continue to advance the clinical understanding of MS and progression with the aim of bringing the most benefit to people living with MS.
About Roche in neuroscience
Neuroscience is a major focus of research and development at Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and autism.
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- Nicolas Dunant