Twice a year! FDA approves new plan for Roche multiple sclerosis drug Ocrevus: Intravenous infusion reduced from 3.5 hours to 2 hours!

December 15, 2020 // -- Roche recently announced that the U.S. Food and Drug Administration (FDA) has approved Ocrevus (ocrelizumab) 2-hour infusion program, a new, shorter-time infusion program that is given twice a year to treat patients with multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS).
in the EU, Ocrevus' two-hour infusion programme was approved in May this year, just one month from the time the application was processed to the time it was approved.
this approval will reduce Ocrevus' intravenous infusion time from 3.5 hours to 2 hours, which will further improve the patient's treatment experience and increase the treatment capacity of the medical system.
medication, Ocrevus is intravenously administered every 6 months.
dose was 300 mg for 2 infusions, with an intermediate interval of 2 weeks, and the follow-up dose was a single 600 mg infusion.
Ocrevus, which was the first in the U.S. in March 2017 and has been approved by 94 countries worldwide to date, is the first and only drug to be approved for the treatment of RMS (including relapsed-remissive MS (RRMS), active or relapsed secondary progressive MS (SPMS), clinical isolation syndrome (U.S. market) and primary progressive multiple sclerosis (PPMS).
the convenience of Ocrevus infusion twice a year can significantly improve patient's treatment compliance.
, the real-world experience of Ocrevus is growing rapidly, with more than 170,000 patients worldwide receiving the drug. "More than 170,000 people worldwide with multiple sclerosis have been treated with Ocrevus, the only B-cell therapy approved twice a year and the most prescribed multiple sclerosis drug in the United States," said Dr. Levi Garraway,
Roche's chief medical officer and head of global product development.
We are constantly working to improve the experience of patients and doctors using our drugs, and we believe that patients with relapsed and primary progressive multiple sclerosis will find it easier to have a shorter 2-hour Ocrevus infusion program."
"Multiple Sclerosis" (Photo: epainassist.com) based on data from the randomized, double-blind ENSEMBLE PLUS study.
The study, conducted in patients with relapsed remission-relieved multiple sclerosis (RRMS), showed that the 2-hour Ocrevus infusion program (289 patients) was consistently safe with the conventional 3.5-hour infusion program (291 patients), and the frequency and severity of the infusion-related reaction (IRR) were comparable.
In this study, the first dose (2 300 mg intravenous (IV) infusions, 2 weeks apart) and the 2nd or subsequent dose (600 mg intravenous infusion) were administered at a shortened 2-hour dose.
the study was the proportion of patients who had IRR (frequency/severity assessed during infusion and after 24 hours) after the first random 600 mg infusion.
data show that the two-hour infusion group (24.6%) and the 3.5-hour infusion group (23.1%) have a similar rate of IRR.
2 groups of IRS were mild or moderate, with more than 98% of IRRs fully resolved, with no complications and no life-threatening, serious or fatal IRRs.
, no patients were interrupted by IRR and no new safety signals were detected.
multiple sclerosis (MS) is a chronic inflammatory, demyelinated central nervous system disease that affects about 2.3 million people worldwide and there is currently no cure for the disease.
MS occurs because the body's immune system abnormally attacks the brain, spinal cord, optic nerve nerve insulation and supporting structure - myelin, causing inflammation and related damage.
can cause a range of symptoms, including visual impairment, muscle weakness, difficulty speaking, severe fatigue, cognitive impairment, etc., which can lead to movement disorders and disabilities.
age of multiple sclerosis is generally between 20 and 40 years old, which is the main cause of trauma and disability in the young adult population.
Ocrevus is an anthoclonated monoclonal antibody that selectively targets CD20-positive B cells, a specific type of immune cell that is considered a key factor in myelin and axon damage that can cause disability in patients with multiple sclerosis (MS).
Preclinical studies have confirmed that Ocrevus selectively binds CD20 cell surface proteins expressed in specific B cells, but does not bind to CD20 proteins on stem cell and plasma cell surfaces, thus preserving important functions of the immune system.
() Original source: FDA approveds Roche's OCREVUS® (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis