May 29, 2020 /
BiovalleyBIOON/ -- Roche has announced that the European Commission (EC) has approved ocrevzumab's two-hour infusion program, a new, shorter-than-life infusion program that is administered twice a year to treat patients with recurrent multiple sclerosis (RMS) or progressive multiple sclerosis (PMS)approval, Ocrevus's intravenous time could be reduced from the current 3.5 hours to two hoursmedication, Ocrevus is intravenously infusioned every 6 monthsThe initial dose was 300 mg for 2 infusions, 2 weeks between intermediate intervals, and the follow-up dose was a single 600 mg infusionit's worth noting that in the Eu,Ocrevus' 2-hour infusion program takes only one month from acceptance to approvalthe program is also receiving U.SThe FDAreview, which is expected to be available on December 14, 2020Ocrevus, which received its first global approval in the United States in March 2017 and has so far been approved by 90 countries worldwide, is the first and only drug approved for the treatment of RMS (including recurrent-resociative MS (RRMS), active or recurrent secondary progressive MS (SPMS), clinical isolation syndrome (US market) and primary progressive multiple sclerosis (PPMS)Ocrevus infusions every 6 months, only 2 times a year, can significantly improve the patient's treatment complianceOcrevus's real-world experience is growing rapidly, with more than 160,000 patients worldwide receiving the drugthis latest approval, based on data from a random, double-blind ENSEMBLE PLUS studyThe study, conducted in patients with recurrent remission multiple sclerosis (RRMS), showed that the 2-hour Ocrevus infusion program (289 patients) had consistent safety with the regular 3.5-hour infusion program (291 patients) and that the frequency and severity of the infusion-related reaction (IRR) were comparable In the study, the first dose of administration under the approved administration programme (2 300 mg intravenous (IV) infusions, 2 weeks apart), and the second or subsequent dose (600 mg intravenous infusion) were administered in accordance with the approved administration programme for a reduced 2-hour programme The main endpoint of the study was the proportion of patients who had an IRR (
the frequency/severity of the assessment during the first randomized 600 mg infusion) data showed that the incidence of IRR in the two-hour infusion group (24.6%) was comparable to that of the 3.5-hour infusion group (23.1%) Both groups of IRR were mild or moderate, with more than 98% of IRR completely resolved, with no complications, and no life-threatening, serious or fatal IRR During the study period, no patients were interrupted by IRR and no new safety signals were detected "European approval of Ocrevus' two-hour infusion, two treatments per year, will further enhance the patient's treatment experience, while also increasing the capacity of the healthcare system," said Dr Levi Garraway, Chief Medical Officer and Global Head of Product Development, Roche More than 160,000 patients worldwide have received Ocrevus treatment, and a shorter infusion time may also help patients and healthcare organizations achieve their ultimate goal of slowing the development of MS "
multiple sclerosis (MS) is a chronic inflammatory, demyelinating central nervous system disease that affects about 2.3 million people worldwide and there is no cure for the disease MS occurs because the body's immune system attacks the brain, spinal cord, optic nerve nerve nerve insulation and support structure - myelin, causing inflammation and related damage This injury can cause a range of symptoms, including visual impairment, muscle weakness, speech difficulties, severe fatigue, cognitive impairment, etc., which can lead to mobility disorders and disability The average age of multiple sclerosis is generally between 20 and 40 years old, which is the main cause of non-traumatic disability in the young and middle age group Ocrevus is a human-derived 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, which can lead to disability in patients with multiple sclerosis (MS) Preclinical studies have shown that Ocrevus selectively binds to CD20 cell surface proteins expressed in specific B cells, but does not bind to CD20 proteins stem cells and plasma cell surfaces, thus preserving important functions of the immune system (biovalleybioon.com) original origin: Roche's OCREVUS (ocrelizumab) shorter 2-hour infusion time app
roved in Europe