USFDA approves Roche’s OCREVUS shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis


Deprecated: strlen(): Passing null to parameter #1 ($string) of type string is deprecated in /home/medicircle/public_html/script_newsdetails.php on line 75
▴ USFDA approves Roche’s OCREVUS shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis
Shorter infusion time will further improve the twice-yearly treatment experience for OCREVUS, the only B-cell therapy for relapsing and primary progressive MS with a twice-yearly dosing schedule

Roche recently announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for OCREVUS (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). The approval was based on data from the randomised, double-blind ENSEMBLE PLUS study.

“More than 170,000 people with MS have been treated with OCREVUS - the only approved B-cell therapy with a twice-yearly dosing schedule - and it is the most prescribed MS medicine in the U.S.,” said Levi Garraway, M.D., PhD., Roche’s Chief Medical Officer and Head of Global Product Development. “We constantly strive to improve the experience that patients and their physicians have with our medicines, and we believe people with relapsing and primary progressive MS will find the shorter two-hour OCREVUS infusion time to be more convenient.”

The ENSEMBLE PLUS study showed similar frequency and severity of IRs for a two-hour OCREVUS infusion time vs. the previously 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 IRs following the first randomised 600 mg infusion (frequency/severity assessed during and 24-hours post infusion). The frequency of IRs 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 IRs were mild or moderate, and more than 98% resolved in both groups without complication. No IRs were life-threatening, serious or fatal. No patients discontinued the study due to an IR and no new safety signals were detected.

The European Medicines Agency (EMA) approved the two-hour infusion time in May of 2020 based on a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

OCREVUS has twice-yearly (six-monthly) dosing and is the first and only therapy approved for relapsing multiple sclerosis (RMS) (including RRMS and active, or relapsing, secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the U.S.) and primary progressive MS (PPMS). OCREVUS is approved in 94 countries across North America, South America, the Middle East, Europe, as well as in Australia.

About OCREVUS (ocrelizumab)
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.

Tags : #Roche #LatestNewsonRoche15thDec #LatestUSFDAApproval15thDec #LatestPharmaNews16thDec #EuropeanMedicinesAgency #LatestTreatmentforMultipleSclerosis15thDec

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

No health, gender and economic justice without ending wars, invasions and genocidesJuly 19, 2025
Venus Remedies Secures WHO GDP Endorsement for Best-in-Class Pharma LogisticsJuly 18, 2025
Single Surgeon Performs 17 Joint Replacements in 8 Hours at CARE Banjara, Setting New Benchmark in Orthopedic ExcellenceJuly 17, 2025
Sterling Hospitals Rajkot Achieves a Medical Milestone: Successfully Treats Rare and Life-Threatening Heart Condition RSOV Without Open Heart SurgeryJuly 17, 2025
Vidyadhan Alumni and Students Successfully Host Third Annual Blood Donation DriveJuly 17, 2025
HOSMAC Signs MoU with Gulf Medical University as Industry Partner to Strengthen Healthcare Education and CollaborationJuly 17, 2025
Why Teens Can’t Wake Up Early: The Hidden Problem of School TimingsJuly 17, 2025
Code Blue to Code Smart: How AI is Reshaping ICU Risk StratificationJuly 17, 2025
TERN Group Launches Its 7th Training Centre - and First Dedicated to Japanese Language & Careers - in GuwahatiJuly 16, 2025
Sri Sathya Sai Heart Hospital Ahmedabad and Rajkot signed an MOU with Gujarat Health Department for free heart surgery for needy children and adults July 16, 2025
No health without rights, says Shobha Shukla SDG-3 Lead Discussant at UN meetJuly 15, 2025
30 Minutes To Freedom, Robotic Surgery Ends 89-YO’s Swallowing NightmareJuly 15, 2025
Himalaya Wellness Champions Bhringaraja in New Anti-Hair Fall Campaign with a Tale of FriendshipJuly 15, 2025
ViiV Healthcare and Medicines Patent Pool extends voluntary licensing agreement to enable access to long-acting injectable HIV treatment July 15, 2025
Reforming global financial architecture is critical for gender equality and right to healthJuly 14, 2025
Francesco Arezzo takes office as president of Rotary InternationalJuly 14, 2025
CBM India Highlights Inclusive Eye Health at VISION 2020: The Right to Sight – INDIA 19th Annual ConferenceJuly 14, 2025
Crompton Introduces Ameo Fresh Nutri Blender, Reinforcing Its Promise of ‘Healthy Choices Made Easy’July 14, 2025
NMC Notifies Medical Institutions (Qualifications of Faculty) Regulations, 2025 to Expand Medical Education Capacity and Strengthen Faculty Availability July 14, 2025
India’s Roads, India’s Pain: Healing Beyond the HospitalJuly 14, 2025