March 28, 2017 News by Patricia Silva, PhD FDA Approves Ocrevus as 1st MS Treatment for Both Relapsing and Primary Progressive Forms At long last, and for the first time in medical history, peopleĀ with both relapsing and primary progressive forms of multiple sclerosis have reason to celebrate. The U.S. Food and Drug Administration (FDA) today approved Ocrevus (ocrelizumab)Ā as a disease-modifying therapy for both forms of MS, aĀ chronic autoimmune disease.
March 28, 2017 News by Patricia Silva, PhD Ocrevus’ Journey from Defiant Idea to Game-Changing Treatment Twenty years ago, the idea that B-cell depletion could treat multiple sclerosisĀ would have been greeted with a hearty laughĀ byĀ any well-respected neurologist or MS researcher ā or perhapsĀ a scoff. But times change and research advances. Today, a medicine that gets rid of certain B-cells may beĀ the most powerful drug yetĀ developed against…
March 17, 2017 News by Patricia Silva, PhD Ocrevus and the Hope of ‘Ending MS Forever’: Interview with MS Societyās Tim Coetzee The potential approval of Ocrevus (ocrelizumab)Ā this monthĀ supports the idea that, someday, a world free of multiple sclerosis (MS) is possible, according to Dr. Tim Coetzee, the National Multiple Sclerosis Societyās chief advocacy, services and research officer. While Coetzee ā and the society he representsĀ ā realize the potential of…
March 17, 2017 News by Patricia Silva, PhD Full Transcript of Interview with Tim Coetzee of the National MS Society Here is a transcript ofĀ Multiple Sclerosis News Today‘s interview with Dr. Tim Coetzee ā chief advocacy, services and research officer for the National Multiple Sclerosis Society ā about the importance of the U.S. Food and Drug Administration (FDA)’s awaitedĀ decisionĀ onĀ Ocrevus (ocrelizumab), and the other ongoing research. Tim…
February 28, 2017 News by Patricia Silva, PhD ‘Ocrevus Has the Potential to Change How MS Is Treated,’ Genentech’s Peter Chin Says in Interview March 28, at the latest, may be a historic date for the multiple sclerosis (MS) community ā patients, families, caregivers, researchers, and physicians alike. The U.S. Food and Drug Administration (FDA) will have its say about the marketing approval forĀ Ocrevus (ocrelizumab). The drugĀ willĀ be the first to offerĀ benefit to…
February 28, 2017 News by Patricia Silva, PhD Full Transcript of Interview with Genentech’s Medical Director, Peter Chin, on Ocrevus BelowĀ is a transcript of theĀ Multiple Sclerosis News TodayĀ interview with Dr. Peter Chin ā principal medical director at Genentech ā about the importance of the pending U.S. Food and Drug Administration (FDA) approval of a Biologics Licensing Application (BLA) for Ocrevus (ocrelizumab). An an indepth article on this interview,Ā lookingĀ Ocrevus…
February 27, 2017 News by Patricia Inacio, PhD #ACTRIMS2017 – Ocrevus Significantly Decreases Disease Activity in MS Patients, Study Shows Ocrevus (ocrelizumab), an investigational monoclonal antibody, significantly decreases disease activity in patients with multiple sclerosis (MS), and is associated with a higher proportion of patients reaching no evidence of disease activity (NEDA), according to a new analysis. The study,Ā āNEDA analysis by epoch in patients with relapsing multiple…
February 24, 2017 News by Patricia Silva, PhD #ACTRIMS2017 – 3 Trials Show MS Patients Receiving Ocrevus Had No Elevated Infection Risk A detailed analysis ofĀ relapsing and primary progressive multiple sclerosis (MS) patients in the three Phase 3 trials of Ocrevus (ocrelizumab) showed that the treatment did not significantly increase their risk of infections ā serious or otherwise. Certain infections, including common colds and influenza, were numerically more common among Ocrevus-treated patients,…
February 23, 2017 News by Patricia Silva, PhD #ACTRIMS2017 – No Evidence of Progression More Likely Among PPMS Patients on Ocrevus Genentechās Ocrevus (ocrelizumab) increased the proportion of patients with no evidence of progression (NEP) in the recently concluded ORATORIO Phase 3 clinical trial in patients with primary progressive multiple sclerosis (PPMS). The evaluation of NEPĀ ā a combined measure of three disability assessments ā was a secondary exploratory endpoint of…
January 19, 2017 News by Patricia Silva, PhD Reports on MS Treatment Market Show Growing Shift to Oral Therapies The multiple sclerosis (MS) market shiftedĀ during 2016, with oral disease-modifying therapies (DMTs) capturing a greater share and Sanofi-Genzyme’s Aubagio (teriflunomide) being poised for growth, according to a press releaseĀ fromĀ Spherix Global Insights. The conclusions were included in the company’sĀ āRealTime Dynamix: Multiple Sclerosis,ā a quarterly report based…
January 4, 2017 Columns by Laura Kolaczkowski FDA’s Delay in Approving Ocrevus is Normal Part of the Process Long-awaited approval of the multiple sclerosis drug Ocrevus (ocrelizumab) has been delayed by the U.S. Food and Drug Administration. What had been publicized widely as a late December 2016 FDA approval hearing has now been pushed to late March 2017. The drugās manufacturer, Genentech, issued a very…
January 4, 2017 News by Joana Fernandes, PhD Top 10 Multiple Sclerosis Articles of 2016 A number ofĀ important discoveries, therapeutic developments, and events related to multiple sclerosis (MS) were reported dailyĀ by Multiple Sclerosis News Today throughout 2016. Now that the year is over, it is time to briefly review the articles that appealed most toĀ ourĀ readers. Here are the top 10 most-read articles of 2016, with…
January 3, 2017 News by Patricia Silva, PhD Ocrevus Seen in Phase 3 Trials to Benefit Both Primary Progressive and Relapsing MS Patients Recently published data from three Phase 3 trials of Ocrevus (ocrelizumab) show that the investigational drug does what no other therapy has achieved so far ā working to prevent disease in both relapsing and primary progressive (PP) forms of multiple sclerosis (MS). Publications in the New England Journal…
December 23, 2016 Columns by Ed Tobias Still Waiting on Ocrevus Several months ago I wrote a blog on my personal websiteĀ aboutĀ Ocrevus (ocrelizumab), the first drug that’s designed specifically to treat primary progressive, as well as remitting, multiple sclerosis. The clinical trials forĀ Ocrevus posted excellent results. The buzz in the medical community was good, Ā and it was…
December 21, 2016 News by Joana Fernandes, PhD FDA Extends Review of Ocrevus as Potential Treatment for Both Forms of MS Until March The U.S. Food and Drug Administration recently extended until the end of March its review of the Biologics License Application (BLA) forĀ Ocrevus (ocrelizumab). The application was submitted by Roche, requesting FDA approval forĀ Ocrevus as a treatment for patients with relapsing-remitting multiple sclerosis (RRMS) and ā for a first…
December 21, 2016 News by Patricia Silva, PhD New Phase 3 Trial of Ocrevus to Treat RRMS Begins Enrolling Patients in US Genentech is recruiting U.S. participants for a Phase 3 study (NCT02637856) of Ocrevus (ocrelizumab) in people with relapsing-remitting multiple sclerosis (RRMS) who were notĀ helped by previous disease-modifying therapies, according to a press release from the National Multiple Sclerosis Society. The trial is an open-label study, meaning…
October 21, 2016 Columns by Ed Tobias MS Drugs – Who’s Using What? Most of us who live with multiple sclerosis also live with a disease modifying therapy (DMT) ā a drug that, we hope, will positively modify the course of our disease. One of the earliest of these was Avonex, a weekly injection into the muscle. I was one of those…
October 13, 2016 News by Patricia Silva, PhD Neurologists Anticipate FDA Approval of Ocrevus as 1st Progressive MS Treatment, Survey Finds Neurologists in the U.S. expect ā or, at least, highly anticipate ā that Ocrevus (ocrelizumab), being developed by Roche as a treatment for both relapsing and progressiveĀ multiple sclerosis (MS), will be approved by year’s end, and a sizableĀ numberĀ plan on quickly prescribing it, according to a recent update byĀ Ā Spherix…
September 23, 2016 News by Patricia Silva, PhD #ECTRIMS2016 – Primary Progressive MS Patients May Soon Have Ocrevus as Treatment Results from the ORATORIO trial, exploring Ocrevus (ocrelizumab) for the treatment of primary progressive forms of multiple sclerosis (MS), showed that the drug stopped disease progression for more than two years in more patients than a placebo. The findings, a highlight at the European Committee for Treatment and Research…
September 15, 2016 News by Joana Fernandes, PhD #ECTRIMS2016 – New Data Show Ocrevus Effective in Treating Primary and Relapsing MS Positive new dataĀ from Phase 3 clinical trials assessingĀ Ocrevus (ocrelizumab) as a treatment for both relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS) were recently announced by Roche, the company responsible for marketing and developing this investigationalĀ therapy. The results are being presented at the 32nd Congress of the…
August 1, 2016 News by InĆŖs Martins, PhD Genentech Enrolling Relapsing MS Patients in Study of Mechanism of Action for Ocrevus In addition to a new study sponsored by GenentechĀ to test the experimentalĀ MS therapyĀ Ocrevus (ocrelizumab)Ā in RMS patients who have had a sub-optimal response to previous disease modifying therapies, the company is also currently recruiting patients with relapsing multiple sclerosis to understand the therapy’sĀ mechanism of action and B-cell biology…
July 21, 2016 News by InĆŖs Martins, PhD Study of Potential Therapy for Relapsing MS That Targets B-Cells Now Recruiting Patients in US Patients with relapsing multiple sclerosis (MS)Ā are being recruited forĀ aĀ clinical trial evaluatingĀ an experimental monoclonal antibody called ublituximab, the National MS Society announced in a recentĀ newsĀ release. The study, being conducted at seven U.S. sites, will enroll at least 24 patients, but this number can go up to 100. MSĀ is considered to be…
July 6, 2016 News by InĆŖs Martins, PhD ICER Draft Report Evaluating Therapies for RRMS Now Open for Public Comment TheĀ Institute of Clinical and Economic Review (ICER)Ā released the early draft of a paper intended toĀ informĀ a future report evaluating the effectiveness and value of disease-modifying therapies for relapsing-remitting multiple sclerosis (RRMS). The paper, called aĀ draft scopingĀ document, is titled “Disease Modifying Therapies for Relapsing-Remitting Multiple Sclerosis: Effectiveness and…
June 29, 2016 News by InĆŖs Martins, PhD 1st Potential Therapy for Primary Progressive MS, Ocrelizumab, Under Priority Review by FDA The U.S. Food and Drug Administration (FDA) is givingĀ priority review to a request to approveĀ Ocrevus (ocrelizumab) as a treatment forĀ both forms of multiple sclerosis, the drug’s developer,Ā Genentech, announced. If the company’s Biologics License Application (BLA) is approved,Ā Ocrevus will become the first drug ableĀ to treat patients with either relapsing or…
June 6, 2016 News by Patricia Silva, PhD #CMSC16 – Ocrevus (Ocrelizumab) in PPMS Prevented Disability Progression, Lowered MRI Lesion Volume, Study Shows Data recently presented at the Consortium of Multiple Sclerosis Centers (CMSC) 2016 Annual Meeting showed that Roche/Genentechās investigational drugĀ ocrelizumab (Ocrevus) lowered the risk of disability progression in primary progressive multiple sclerosis (PPMS), a condition for which no approved treatments exist. The study was presented during the “…
June 6, 2016 News by InĆŖs Martins, PhD #CMSC16 – Genentech’s Ocrelizumab (Ocrevus) a Promising Therapy for Primary Progressive MS; Interview with Lead Researcher Genentech,Ā a member of the RocheĀ Group, was founded more than 35 years ago and has been focused on a variety of research fields, includingĀ cancer, immunology, neurodegenerative disorders, metabolic diseases, and infectious diseases. Genentech has been committed to discovering and developing new medicines for patients with major diseases of the nervous…
April 14, 2016 News by Patricia Silva, PhD Genentech to Present New Data from Phase 3 Trials of Ocrevus in MS Patients at AAN Annual Meeting GenentechĀ announced that it will present new data from three Phase 3 clinical trials ofĀ its experimental multiple sclerosis (MS) therapyĀ Ocrevus (ocrelizumab) at the 68th annual meeting of the American Academy of Neurology (AAN) being held in Vancouver, Canada, from April 15ā21, 2016. Additionally, results of a new endpoint for…
February 18, 2016 News by BioNews Staff FDA Grants ‘Breakthrough Therapy’ Designation to Genentechās Ocrelizumab for PPMS Genentech recently announced that the U.S. Food and Drug Administration (FDA) granted its investigational medicine ocrelizumab, a potential treatment forĀ primary progressive multiple sclerosis (PPMS),Ā Breakthrough Therapy DesignationĀ based on positiveĀ Phase 3 clinical trial results showing thatĀ ocrelizumab significantly reduced disability progression and other disease activity markers compared toĀ placebo. The FDA designation is…