{"id":399341,"date":"2020-12-14T15:18:23","date_gmt":"2020-12-14T20:18:23","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=399341"},"modified":"2020-12-14T15:18:23","modified_gmt":"2020-12-14T20:18:23","slug":"fda-approves-genentechs-ocrevus-ocrelizumab-shorter-2-hour-infusion-for-relapsing-and-primary-progressive-multiple-sclerosis","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-genentechs-ocrevus-ocrelizumab-shorter-2-hour-infusion-for-relapsing-and-primary-progressive-multiple-sclerosis\/","title":{"rendered":"FDA Approves Genentech\u2019s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis"},"content":{"rendered":"

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FDA Approves Genentech\u2019s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis<\/b><\/p>\n

\n\u2013 Approval based on data from the randomized, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional Ocrevus dosing regimen \u2013<\/i><\/p>\n

\n\u2013 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<\/i>\u2013<\/i><\/p>\n

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE<\/a>)–
\nGenentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for Ocrevus\u00ae<\/sup> (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 randomized, double-blind ENSEMBLE PLUS study.\n<\/p>\n

\n\u201cMore than 170,000 people with MS have been treated with Ocrevus \u2013 the only approved B-cell therapy with a twice-yearly dosing schedule \u2013 and it is the most prescribed MS medicine in the U.S.,\u201d said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. \u201cWe 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.\u201d\n<\/p>\n

\nThe 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.\n<\/p>\n

\nThe primary endpoint of this study was the proportion of patients with IRs following the first randomized 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.\n<\/p>\n

\nThe European Medicines Agency (EMA) approved<\/a> the two-hour infusion time in May of 2020 based on a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).\n<\/p>\n

\nOcrevus 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.\n<\/p>\n

About multiple sclerosis<\/b><\/p>\n

\nMultiple sclerosis (MS) is a chronic disease that affects nearly one million people in the United States, for which there is currently no cure. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the brain, spinal cord and optic nerves, causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults.\n<\/p>\n

\nRelapsing-remitting MS (RRMS) is the most common form of the disease and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 85 percent of people with MS are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to secondary progressive MS (SPMS), in which they experience steadily worsening disability over time. Relapsing forms of MS (RMS) include people with RRMS and people with SPMS who continue to experience relapses. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15 percent of people with MS are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus, there had been no FDA approved treatments for PPMS.\n<\/p>\n

\nPeople with all forms of MS experience disease activity \u2013 inflammation in the nervous system and permanent loss of nerve cells in the brain \u2013 even when their clinical symptoms aren\u2019t apparent or don\u2019t appear to be getting worse. An important goal of treating MS is to reduce disease activity as soon as possible to slow how quickly a person\u2019s disability progresses. Despite available disease-modifying treatments (DMTs), some people with RMS continue to experience disease activity and disability progression.\n<\/p>\n

About Ocrevus<\/b>\u00ae<\/sup> (ocrelizumab)<\/b><\/p>\n

\nOcrevus is the first and only therapy approved for both RMS (including clinically isolated syndrome, RRMS and active, or relapsing, SPMS) and PPMS, with dosing every six months. Ocrevus is a humanized 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.\n<\/p>\n

\nOcrevus 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.\n<\/p>\n

Indications and Important Safety Information<\/b><\/p>\n

What is Ocrevus?<\/b><\/p>\n

\nOcrevus is a prescription medicine used to treat:\n<\/p>\n