April 6, 2018 News by Jose Marques Lopes, PhD New MS Therapy Company, Pipeline, to Focus on Rejuvenating Coating That Protects Nerve Cells A new company called Pipeline Therapeutics will focus on developing next-generation therapies for regenerating the key nerve-protection process that is damaged in multiple sclerosis. Roche, Inception Sciences,Ā and the venture capital firmĀ Versant VenturesĀ laid the groundwork for Pipeline byĀ establishing a partnershipĀ in June 2014 that formed the…
February 16, 2018 News by Alice MelĆ£o, MSc Health Canada Approves Ocrevus to Treat Early Stage PPMS Patients with Active Disease Primary progressive multiple sclerosis (PPMS) patients in Canada in the earlier stages of this disease can now be treated with Ocrevus (ocrelizumab), followingĀ Health Canada‘s decision to approve its use with restrictions. Roche/Genentechās Ocrevus can be prescribed to adults with early-stage PPMS and characteristic signs of…
February 2, 2018 News by Patricia Silva, PhD #ACTRIMS2018 – Relapsing MS Patients With Impaired Vision Improved on Ocrevus, Updated Trial Data Show Ocrevus improved vision among relapsing multiple sclerosis patients who participated in the Phase 3 clinical trials of the treatment, according to updated analyses recently presented at the ACTRIMSĀ Forum 2018. While Ocrevus-treated patients improved their ability to read low-contrast letters over the course of the two trials, people who received Rebif (interferon beta-1a) did not. Laura J. Balcer, a neurologist at New York University Langone Medical Center, shared the data in a presentation titled, āEffect of Ocrelizumab on Visual Outcomes in Patients with Baseline Visual Impairment in the OPERA Studies in Relapsing Multiple Sclerosis.ā Balcer had earlier shared data on the visual outcomes of relapsing patients in the OPERA I and OPERA II Phase 3 clinical trials of Ocrevus at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, last year. The two studies āĀ sponsored by Ocrevus developer Genentech, a member of the Roche group ā Ā compared Ocrevus and Rebif in patients with relapsing MS. This time, her presentation focused only on patients who had visual impairment when they enrolled in the trials. Among a total of 1,656 participants, 375 of those treated with Ocrevus and 373 in the Rebif group had visual impairment. Researchers tested vision using a low-contrast letter acuity test. The test is similar to an ordinary vision test, with letters of different sizes on a chart. But the low-contrast test uses gray lettersĀ ā instead of black ā on a white background. Researchers included charts with two shades of gray to test different contrast levels. These tests can detect reduced visual function. At the beginning of the trials, both groups performed in a similar manner āĀ correctly identifying about 35 letters on a chart with somewhat higher contrast. After 96 weeks, those receiving Ocrevus identified on average 3.4 more letters, while Rebif-treated patients worsened by 0.5 letters ā a significant difference, Balcer said. Researchers tested vision every 12 weeks. At the end of the trials, they found that 39 percent more patients in the Ocrevus groups had a cumulative improvement of at least 10 letters, compared to those treated with Rebif. At this time, 26.4 percent of Ocrevus-treated patients improved 10 letters or more, compared to 19.8 percent in the Rebif group. The difference between the groups for at least seven letters was 54 percent, with Ocrevus-treated patients performing better. Researchers believe that a seven-letter change is the minimal clinically important difference for the test. Based on the results, researchers believe that the findings demonstrate Ocrevusā ability to reverse visual impairment in relapsing MS. The ACTRIMS Forum 2018 isĀ being held in San Diego, California, Feb. 1ā3.
January 22, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: Ocrevus in the EU, Salt and Cognitive Problems, Searching for Myelin, Tecfidera Tolerance European Commission Approves Ocrevus to Treat RRMS, PPMS Throughout EU This is a biggie. It’s been nearly a year since the FDA approved the use of Ocrevus here in the U.S. Finally, it’s been given the green light in Europe. Canada, Australia, Switzerland, and various countries in…
January 15, 2018 News by Patricia Silva, PhD European Commission Approves Ocrevus to Treat RRMS, PPMS Throughout EU The European Commission has approved Roche’sĀ Ocrevus (ocrelizumab) for both relapsing-remitting multiple sclerosis (RRMS) and primary-progressive multiple sclerosis (PPMS) across the 28-member European Union. The commissionās move ā Ā nearly 10 months after the U.S. Food and Drug Administration (FDA)Ā approvedĀ Ocrevus in March 2017 ā makes it the first approved PPMS…
November 28, 2017 News by Patricia Silva, PhD European Neurologists Ready to Use Both Mavenclad and Ocrevus, Survey Shows Mavenclad has become the multiple sclerosis therapy of choice for one in five neurologists in Germany and the United Kingdom,Ā according to a Spherix Global InsightsĀ survey. Meanwhile, many European neurologists are looking forward to the continent's approval of Ocrevus, particularly as a treatment for primary progressive multiple sclerosis, or PPMS. The United States approved the therapy in March of 2017. European neurologists are using Mavenclad for both relapsing-remitting multiple sclerosis, or RRMS, and secondary progressive multiple sclerosis, SPMS. The report that Spherix issued on European neurologists' treatment choices is calledĀ "RealTime Dynamix: Multiple Sclerosis EU."Ā It was based on a survey of 261 neurologists, who were asked about thei disease-modifying drugs they prescribed and the way they manage MS, according toĀ a press release. The survey focused on Merck KGaAās Mavenclad, whichĀ the European Union approved in August 2017, and Genentechās Ocrevus, which the European Commission is expected to approve soon. The European Medicines Agency paved the way for approval byĀ recommending its authorization earlier this month. Mavenclad is the first disease-modifying therapy that most of the patients who are on it have tried, according to the survey. Spherix analysts said this indicates that Mavenclad may expand the proportion of MS patients using disease-modifying drugs. But while Mavencladās label allows patients to use it as a first-line therapy, the survey revealed that many neurologists are not comfortable prescribing it as an initial treatment. This suggests that the Mavenclad-treated population may later include more patients who switched treatments, Spherix said. Mavenclad reduces MS relapses by resetting the immune system, studies have shown. Neurologists who prescribe it as a first-line treatment appear to endorse the idea of induction therapy. This approach involves more potent therapies being used from the onset of the disease.Ā British neurologists in particular appear to favor the induction approach, the report revealed. Patients who had been on previous treatments have switched mainly from Copaxone (glatiramer acetate), interferons, or Novartis' Gilenya, the report showed. Many neurologists' lack of familiarity with Mavenclad may be limiting its use, the report said. It noted that two out of five neurologists had not received a detailed briefing on the drug, and more than one-third had not attended any launch activities. Limited market access was the second most common obstacle to Mavenclad prescription, the report indicated. Interestingly, those who had participated in Mavenclad launch activities said these consisted mostly of independent research or discussions with colleagues, rather than activities organized by Mavencladās developer Merck KGaA. Spherixās survey was done just before the European Medicines Agency recommended Ocrevus' approval in mid-November. Even before the endorsement, the survey indicated, Ocrevus was by far the MS drug in development that most neurologists looked forward to using. The reasons, the neurologists said, were its beneficial effectiveness-safety profile, its new mechanism of action, the fact that it only needs to be given once every six months, and a treatment label that includes PPMS. It is the first disease-modifying drug ever approved for PPMS patients. Twice as many neurologists said they look forward to using Ocrevus as a first-line treatment for PPMS as those saying they wanted to use it as a first-line treatment for relapsing MS. And neurologists estimated that twice as many PPMS patients as RRMS patients are appropriate candidates for Ocrevus treatment. In a report in October about U.S. neurologists' treatment preferences, Spherix said those doctors estimated the number of PPMS Ocrevus candidates at three times that of RRMS patients. Nonetheless, about equally as many PPMS and RRMS patients had tried Ocrevus four months after its launch, the survey showed. The European situation may evolve in a similar manner, since the European Medicines Agency recommended a specific use of Ocrevus in PPMS patients. It specified that the drug be used in PPMS patients who show āimaging features characteristic of inflammatory activity."Ā This makes it likely that only a subgroup of PPMS patients will receive the treatment. The use of Biogen's Tysabri, Gilenya, and Rituxan (rituximab), also made by Roche'sĀ Genentech subdivision, will be most impacted by Ocrevus' introduction. Despite this, neurologists believe rituximab's use will grow in the next six months, because Ocrevus is still not available, while lower-cost rituximab biosimilars are.
November 9, 2017 Columns by Laura Kolaczkowski Ocrevus Q&A, Part 2 Editor’s note: This is the second of a two-part series on readers’ comments about Ocrevus (ocrelizumab). Read part one here. Last week, I responded to a few comments on columns regarding my personal experience with Ocrevus (ocrelizumab). Here are more reader comments and my answers.
November 2, 2017 Columns by Laura Kolaczkowski Ocrevus Q&A, Part 1 Editor’s Note: First in a two-part series on readers’ comments about Ocrevus (ocrelizumab). I switched disease-modifying therapies and began treatment with Ocrevus (ocrelizumab)Ā in June. I previously wrote about my reasons for switching, my experiences with the first two doses, and more recently, about any…
October 31, 2017 News by Patricia Silva, PhD #MSParis2017 – Scant Difference Seen in Inflammatory Response to Ocrevus or Rituxan in Small Study Both Ocrevus (ocrelizumab) and Rituxan (rituximab) trigger a similar release of inflammatory mediators after a first infusion, with little difference seen in infusion reactions among a small group ofĀ multiple sclerosis (MS) patients treated with either therapy, said researchers from the Rocky Mountain MS Center at the University of…
October 17, 2017 News by Patricia Silva, PhD #MSParis2017 – Genentech to Share Host of New Ocrevus Data at ECTRIMS-ACTRIMS Meeting GenentechĀ will present a host of new information on its multiple sclerosis treatmentĀ OcrevusĀ and lessons its scientists have learned about the disease at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25ā28. The presentations will offer new insights into the therapy's mechanisms, safety and effectivenessĀ in people with the primary progressive and relapsing forms of MS. They will also look at new ways to track MS, including additional biomarker possibilities. MS experts say the joint meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) is one of the largest global congregations of scientists working on the disease. The information Genentech plans to present will demonstrate "the commitment of our scientists and research partners to advance understanding of MS progression through ongoing analyses of the Ocrevus Phase 3 clinical trials,ā Dr. Sandra Horning, the company's chief medical officer and head of its Global Product Development arm, said in a press release. Genentech, which is part of the Roche group, said the 18 presentations will represent the largest body of evidence ever presented on Ocrevus. The discussions will reinforce the therapy's favorable benefit-risk profile, Genentech added. Two presentations will cover new ways that doctors can look for signsĀ of disease activity that can lead to disability. One yardstick is calledĀ progression independent of relapse activity, or PIRA. AnotherĀ is tracking slowly evolving lesions. Genentech researchers came up with the approaches when they analyzed a subgroup of patients in the OPERA I and OPERA II Phase 3 clincal trials, whose aim was to evaluate Ocrevus as a treatment for relapsing MS. The patients' disease progressed even though they had no relapses, researchers said. The team will also discuss how Ocrevus affected these patients' disease. Another presentation will cover long-term follow-up data from an extension of the ORATORIO Phase 3 clinical trial (NCT01194570), which dealt with Ocrevus' ability to treat primary progressive MS. It will Ā look at how well Ocrevus slowed the progression of patients' disability. Updated information on Ocrevusā safety āĀ based on open-label extension studies āĀ will be another component of the presentations. So far, researchers have detected no new safety issues. Genentech will also discuss a new way of using conventional magnetic resonance imaging (MRI) to identify and track slowly evolving lesions. The company's scientists think that tracking the lesions may be a good way to measure chronic disease activity. This would contrast with tracking ordinary MS lesions, which are biomarkers of acute ā as opposed to chronic ā disease activity. In addition to "two new potential markers of underlying disease activity and their impact on disease progression, we hope to bring new tools to the MS community to better understand and manage the disease,ā Horning said. One tool, which Genentech has begun testing in clinical trials, is gathering patient information with sensors connected to a smartphone. Researchers are comparing the information obtained in the FLOODLIGHT study with what physicians record during patient visits. The research team believes the FLOODLIGHT method may beĀ be able to detect subtle changesĀ better. This could make it a better predictor of disease activity and long-term patient outcomes. In addition to the presentations, Genentech will sponsor two symposia at the meeting that will discuss how MS progresses, features of the chronic version of the disease, and the link between inflammation and the progression of MS. The U.S. Food and Drug AdministrationĀ approved Ocrevus in March 2017. Ā
September 29, 2017 News by Patricia Silva, PhD Switzerland First in Europe to Approve Ocrevus for Relapsing and Primary Progressive MS Swiss regulatory authorities approved Ocrevus as a treatment for primary progressive and relapsing forms of multiple sclerosis on Sept. 28, making it the first approval of the drug in a European country. Since Switzerland is not part of the European Union, the approval will not affect the drug's regulatory status in other European countries. So far, the Roche/Genentech drug Ocrevus has been approved in North America, South America, the Middle East, Ukraine, and Australia. Like other countries where Ocrevus has been approved, it's the first drug OK'dĀ in Switzerland for primary progressive MS, a form of the disease where disability moves forward relentlessly. And, as in other countries, the treatment option is equally appreciated among patients with relapsing types of MS. Ocrevus āĀ an antibody that targets B-cells with the surface factor CD20 āĀ was studied in two large Phase 3 trials in patients with relapsing MS called OPERA I and OPERA II (NCT01247324 and NCT01412333). Another trial, called ORATORIO (NCT01194570), is focused on people with primary progressive disease. The trials showed that the treatment significantly reduced disease activity and prevented progression in both patient groups. Researchers compared Ocrevus to Rebif (high-dose interferon beta-1a) in relapsing MS and to a placebo in primary progressive MS. Scientists also consider the drug to have a good safety profile. The most common side effects during the trials were mild-to-moderate infusion reactions and upper respiratory tract infections. Since its approval, researchers also have concluded that the treatment is less expensive than interferon. Ocrevus was approved in the U.S. on March 28, 2017. In the months that followed, many patients were concerned about the trial findings of more cancer cases in the treated, compared to control, groups. Since then, an increased risk of cancer with Ocrevus has not been confirmed, and researchers underscore that it is instead the coincidental and unusual circumstance that there were no cancer cases in the control group that created the imbalance. The European Medicines Agency is still processing the marketing application for Ocrevus. Roche reports that the company has filed marketing applications in more than 50 countries worldwide.
August 17, 2017 News by Patricia Inacio, PhD Ocrevus Approved in Canada to Treat Relapsing-Remitting MS Health Canada has approved Ocrevus for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) with active disease, Roche Canada announced. The approval followed the positive results from the Phase 3 OPERA studies, which evaluated the safety and efficacy of Ocrevus in 825 patients with RRMS. The OPERA 1 and OPERA 2 trials showed that Ocrevus significantly reduced disease activity and disability progression of RRMS patients, with annual relapse rates falling by almost half. Moreover, Ocrevus outperformed Rebif, the standard of care in MS, in slowing worsening of disability and significantly reducing lesions seen on MRI scans over a two-year treatment period. "Ocrevus is a major addition to the treatment options available for MS. The RRMS Ocrevus clinical trial data show a significant reduction in relapses and disease progression, as well as a good safety profile," Daniel Selchen, a neurologist and head of the Division of Neurology at St. Michael's Hospital in Toronto, said in a press release. "For appropriate patients, Ocrevus will be of great value in reducing the burden of MS." The treatment's approval, however, did not extend to ā or mention ā people with primary progressive MS, in contrast to the U.S. Food and Drug Administration's action in March, which approved Ocrevus for both MS forms. Health Canada did not give address PPMS in its announcement. Estimates are that 100,000 Canadians are currently living with MS, and most have the relapsing form. A number welcomed Ocrevus' arrival for what it offers in their fight against this disease.
June 6, 2017 News by Patricia Silva, PhD Ongoing Ocrevus Trials Seek More Knowledge of Treatment Effects and MS Patients’ Benefits Ocrevus (ocrelizumab), a recently approvedĀ therapy for relapsing and primary progressive multiple sclerosis (MS),Ā is now on the U.S. market, but research intoĀ itsĀ use is far from over. Several clinical trials, sponsored by Ocrevus’ developer Genentech or its parent company Roche, are looking at various aspectsĀ of the treatment. Multiple Sclerosis…
May 30, 2017 News by Patricia Inacio, PhD #CMSC17 – Ocrevus Lowers MS Relapse Rates Even Further in Extension Study Multiple sclerosis patients who benefited fromĀ Ocrevus (ocrelizumab)Ā in two Phase 3 clinical trials continued to benefit when they extended their treatment, researchers reported. In fact, their annual relapse rates have fallen even further during the extension study than during the trials. The study, āPreliminary Results of the OPERA I and…
May 25, 2017 News by Patricia Silva, PhD PML Found in Ocrevus-Treated Patient Who Had Used Tysabri for 3 Previous Years A multiple sclerosis (MS) patient treated in Germany withĀ Ocrevus (ocrelizumab)Ā has developed the dreaded brain infection progressive multifocal leukoencephalopathy (PML).Ā But it is not clear whether the recently approvedĀ Genentech/Roche-developed treatmentĀ is the cause. The patient took the last dose of a three-year course of Tysabri (natalizumab)Ā in February. Tysabri is…
April 27, 2017 News by Patricia Silva, PhD Genentech Highlights Rapid Actions of MS Therapy Ocrevus at AAN Meeting Within the first two months of treatment, Ocrevus (ocrelizumab) reduced relapses in multiple sclerosis (MS) patients by more than half compared to those on Rebif, and almost completely prevented new brain lesions, according to data underscoring the drug’s rapid effects. Researchers from San Francisco-basedĀ Genentech and its Swiss parent…
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…
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…
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…
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…
November 11, 2015 News by Patricia Silva, PhD Roche to Pursue MS Ocrelizumab Drug Market Authorization RocheĀ 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…
October 10, 2015 News by Patricia Silva, PhD EXCLUSIVE: Genentech/Roche Interview with MS News Today on Promising MS Therapy Ocrelizumab #ECTRIMS 2015 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 companyās promising multiple sclerosis (MS) therapy…
July 1, 2015 News by Patricia Silva, PhD Rocheās Ocrelizumab Found to be Superior to Standard Interferon Therapy in Relapsing Multiple Sclerosis Patients Roche recently announced encouraging results on its investigational medicine ocrelizumab as a therapy for patients with relapsing multiple sclerosis, which includesĀ either RRMS or SPMS with relapses. Ocrelizumab was evaluated in two pivotal studies (OPERA I and OPERA II), where it was compared to interferon (IFN) beta-1a (RebifĀ®), the standard-of-care…
June 25, 2014 News by Patricia Silva, PhD Roche Turns to MS Research on Agreement with Versant Ventures The Swiss pharmaceutical companyĀ RocheĀ recently announced a partnership agreement with California-based Inception Sciences and venture capital firm Versant Ventures. The three companies will work together to form a new company, Inception 5, which will be dedicated mostly to the development of therapies for multiple sclerosis. Inception 5’s research will focus…