Ocrevus

March 28, at the latest, may be a historic date for the multiple sclerosis (MS) community — patients, families, caregivers, researchers, and physicians alike. The U.S. Food and Drug Administration (FDA) will have its say about the marketing approval for Ocrevus (ocrelizumab). The drug will be the first to offer benefit to…

Below is a transcript of the Multiple Sclerosis News Today interview with Dr. Peter Chin — principal medical director at Genentech — 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, looking Ocrevus…

Editor’s note: Columnist Laura Kolaczkowski writes from the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) 2017 Forum in Orlando, Fla., (Feb. 23-25). Two MS disease-modifying therapies, Ocrevus (ocrelizumab) and Rituxan (rituximab) were featured in this year’s Kenneth P. Johnson, MD, Memorial Lecture…

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, “NEDA analysis by epoch in patients with relapsing multiple…

A detailed analysis of 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 — serious or otherwise. Certain infections, including common colds and influenza, were numerically more common among Ocrevus-treated patients,…

Genentech’s 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 NEP — a combined measure of three disability assessments — was a secondary exploratory endpoint of…

Oral multiple sclerosis meds appear, more and more, to be the first choice of patients who are just beginning to receive an MS treatment. A recent report by the independent marketing research firm Spherix Global Insights shows that oral disease-modifying therapies captured a significantly higher…

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 drug’s manufacturer, Genentech, issued a very…

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 — working to prevent disease in both relapsing and primary progressive (PP) forms of multiple sclerosis (MS). Publications in the New England Journal…

  Several months ago I wrote a blog on my personal website about Ocrevus (ocrelizumab), the first drug that’s designed specifically to treat primary progressive, as well as remitting, multiple sclerosis. The clinical trials for Ocrevus posted excellent results. The buzz in the medical community was good,  and it was…

The U.S. Food and Drug Administration recently extended until the end of March its review of the Biologics License Application (BLA) for Ocrevus (ocrelizumab). The application was submitted by Roche, requesting FDA approval for Ocrevus as a treatment for patients with relapsing-remitting multiple sclerosis (RRMS) and — for a first…

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 not 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…

Here, I comment on my Pick of the Week’s News, as published in Multiple Sclerosis News Today. Myelin Regeneration Achieved in Mouse Model of MS Remyelination is one of the most exciting developments in the treatment of MS. Therapies aimed at regenerating the myelin sheath can work to…

Neurologists in the U.S. expect — or, at least, highly anticipate — that Ocrevus (ocrelizumab), being developed by Roche as a treatment for both relapsing and progressive multiple sclerosis (MS), will be approved by year’s end, and a sizable number plan on quickly prescribing it, according to a recent update by  Spherix…

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…

Positive new data from Phase 3 clinical trials assessing 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 investigational therapy. The results are being presented at the 32nd Congress of the…

Here is my Pick of the Week’s News, from articles published on Multiple Sclerosis News Today.  Antioxidant Therapies Seen as Promising Approach in Treating MS and Like Diseases Maybe antioxidant research could provide another avenue of MS therapy. A review article published in the British…

In addition to a new study sponsored by Genentech to test the experimental MS therapy Ocrevus (ocrelizumab) 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’s mechanism of action and B-cell biology…

A Phase 3 clinical trial exploring Ocrevus (ocrelizumab) in patients with relapsing-remitting multiple sclerosis (RRMS) is now recruiting participants. The trial, sponsored by Genentech (NCT02637856), is seeking patients who have previously taken a disease-modifying treatment that did not adequately control their disease activity. Participants must be between 18 and 55…

Quite a mixed bag in the pick of the week’s news: A drug in development, microbiota in the gut, statins and MS, DMTs and cognitive skills, and images of depression. Endece Granted New U.S. Patent for NDC-1308, Therapy to Induce Remyelination in MS This is a bit of an…

The U.S. Food and Drug Administration (FDA) is giving priority review to a request to approve Ocrevus (ocrelizumab) as a treatment for both forms of multiple sclerosis, the drug’s developer, Genentech, announced. If the company’s Biologics License Application (BLA) is approved, Ocrevus will become the first drug able to treat patients with either relapsing or…

Data recently presented at the Consortium of Multiple Sclerosis Centers (CMSC) 2016 Annual Meeting showed that Roche/Genentech’s investigational drug 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 “…

Genentech, a member of the Roche Group, was founded more than 35 years ago and has been focused on a variety of research fields, including 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…

Genentech announced that it will present new data from three Phase 3 clinical trials of its experimental multiple sclerosis (MS) therapy Ocrevus (ocrelizumab) at the 68th annual meeting of the American Academy of Neurology (AAN) being held in Vancouver, Canada, from April 15–21, 2016. Additionally, results of a new endpoint for…

Clinical trials have shown that ocrelizumab — an antibody targeting B-cells — is effective in multiple sclerosis (MS). As a result, some researchers and clinicians claim that B-cell depletion is a sufficient therapy in MS, and that drugs targeting other immune cells are obsolete. Not everyone agrees. A debate at…

Genentech recently announced that the U.S. Food and Drug Administration (FDA) granted its investigational medicine ocrelizumab, a potential treatment for primary progressive multiple sclerosis (PPMS), Breakthrough Therapy Designation based on positive Phase 3 clinical trial results showing that ocrelizumab significantly reduced disability progression and other disease activity markers compared to placebo. The FDA designation is…

Roche recently provided an update on their late-stage pipeline products across several therapeutic areas, including ocrelizumab for the treatment of multiple sclerosis. The data was disclosed on Nov. 5 at the Roche Pharma Day 2015 event in London, U.K. Ocrelizumab was previously revealed to be the first investigational medicine…

Ocrelizumab, an anti-CD20 monoclonal antibody, targets mature B-cells. Almost 95% of the B-cell population has these antigenic epitopes after maturation and does not shed them, which is what makes it a potent marker for therapeutic purposes (cancer being a very common area of interest in this regard). Read more…

A session titled “Late Breaking News” was featured at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Oct. 7-10, 2015, in Barcelona, Spain. At this session, Prof. Xavier Montalban from the Hospital Vall d’Hebron University in Barcelona presented data on the promising Genentech/Roche…

Dr. Peter Chin, a renowned neurologist and Principal Medical Director of Global Neuroscience Development at Genentech, a leading biotechnology company and member of the Roche Group, participated in an exclusive interview with Multiple Sclerosis News Today correspondent Dr. Ana de Barros on the company’s promising multiple sclerosis (MS) therapy…