Ocrevus

January 15, 2018 News by Patricia Silva, PhD

European Commission Approves Ocrevus to Treat RRMS, PPMS Throughout EU

The European Commission has approved Roche’s Ocrevus (ocrelizumab) for both relapsing-remitting multiple sclerosis (RRMS) and primary-progressive multiple sclerosis (PPMS) across the 28-member European Union. The commission’s move —  nearly 10 months after the U.S. Food and Drug Administration (FDA) approved Ocrevus in March 2017 — makes it the first approved PPMS…

January 11, 2018 Columns by Laura Kolaczkowski

My Ocrevus Treatments: The Next Round Is Delayed

  By now, I had planned to give you an update on my current multiple sclerosis disease-modifying therapy Ocrevus (ocrelizumab). But one thing living with multiple sclerosis teaches us is to not count on plans always working out as we had hoped. Timing really is everything…

January 5, 2018 News by Patricia Silva, PhD

Top 10 Multiple Sclerosis Articles of 2017

Multiple Sclerosis News Today brought you daily coverage of important discoveries, treatment developments, clinical trials, and other events dealing with multiple sclerosis throughout 2017. We look forward to providing more news to MS patients, family members, and caregivers during 2018. As a reminder of what mattered most to you in…

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, according to a Spherix Global Insights 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 called "RealTime Dynamix: Multiple Sclerosis EU." 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 to a press release. The survey focused on Merck KGaA’s Mavenclad, which the European Union approved in August 2017, and Genentech’s Ocrevus, which the European Commission is expected to approve soon. The European Medicines Agency paved the way for approval by 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 Mavenclad’s 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. 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 Mavenclad’s developer Merck KGaA. Spherix’s 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 “imaging features characteristic of inflammatory activity." 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's 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 14, 2017 News by Alice Melão, MSc

Europe’s CHMP Urges Approval of Ocrevus in EU to Treat Relapsing, Primary Progressive MS

Europeans with relapsing multiple sclerosis (MS) and early primary progressive MS are one step closer to accessing Ocrevus, now that the European Medicines Agency has urged the European Union to approve the therapy. The positive opinion — announced in a press release issued Nov. 10 by the EMA’s Committee for Medicinal Products for Human Use — is an intermediary step required in the regulatory pathway to allow patient access to a new drug. The European Commission will now make a final decision on whether Ocrevus should be granted marketing authorization in all 28 EU member states. This decision will take the CHMP recommendation into consideration. If approved, Ocrevus will become the first disease-modifying medicine available throughout Europe for patients with PPMS. Once this happens, any decisions on price or insurance reimbursements will be the responsibility of each member state. Ocrevus won U.S. approval earlier this year. It was also recently approved in Switzerland for both relapsing MS and PPMS. Ocrevus is an anti-CD20 antibody developed by Genentech, a division of Roche. It blocks immune B-cells, preventing them from attacking nerve cells and their myelin protective sheath, as well as inhibiting other pro-inflammatory immune signals involved in MS. CHMP based its positive recommendation on data from three pivotal Phase 3 clinical trials: the OPERA I and II trials in relapsing MS patients, and the ORATORIO trial in PPMS patients. Results from the OPERA clinical studies demonstrated that treatment with Ocrevus for up to 96 weeks could reduce the annualized relapse rate by 46.4 percent compared with EMD Serono’s approved drug Rebif (interferon beta-1a) in relapsing MS patients. The ORATORIO trial showed that Ocrevus could reduce by 24 percent the risk of 12-week confirmed disability progression compared to placebo in PPMS patients. Data from the trial further supported the drug's therapeutic benefit in early-stage PPMS patients. Additional studies are warranted to better evaluate the therapeutic potential of Ocrevus for patients with more advanced stages of the disease. The most common treatment-associated adverse effects reported wee infusion-related reactions and infections.

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) in June. I previously wrote about my reasons for switching, my experiences with the first two doses, and more recently, about any…

October 27, 2017 News by Patricia Silva, PhD

#MSParis2017 – Ocrevus Improves Relapsing MS Patients’ Vision Better Than Interferon, Trials Show

Genentech’s Ocrevus (ocrelizumab) improved the vision of people with relapsing multiple sclerosis better than the widely used therapy interferon beta-1a, according to clinical trial findings presented at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris. Dr. Laura Balcer of the department of neurology at New York University made the presentation, titled “Effect…

October 17, 2017 News by Patricia Silva, PhD

#MSParis2017 – Genentech to Share Host of New Ocrevus Data at ECTRIMS-ACTRIMS Meeting

Genentech will present a host of new information on its multiple sclerosis treatment Ocrevus and lessons its scientists have learned about the disease at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25–28. The presentations will offer new insights into the therapy's mechanisms, safety and effectiveness 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,” 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 signs of disease activity that can lead to disability. One yardstick is called progression independent of relapse activity, or PIRA. Another 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   look at how well Ocrevus slowed the progression of patients' disability. Updated information on Ocrevus’ safety —  based on open-label extension studies — 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 — as opposed to chronic — 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,” 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 be be able to detect subtle changes 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 Administration approved Ocrevus in March 2017.  

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'd 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 — an antibody that targets B-cells with the surface factor CD20 — 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 31, 2017 Columns by Laura Kolaczkowski

Ocrevus and Sweating Out MS

Many of you are considering making the switch to Ocrevus (ocrelizumab) as your disease-modifying therapy for multiple sclerosis. This is a switch I made recently. There are so many questions and unknowns about how this treatment might help me, and I’m trying to…

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 — or mention — 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.

July 28, 2017 Columns by Ed Tobias

MS Therapies: What’s Hot, What’s Not

Ocvevus (ocrelizumab) is off to a running start, Tecfidera (dimethyl fumarate) leads the pills and the four injectable multiple sclerosis drugs are being used by fewer MS patients. But Copaxone (glatiramer acetate injection) remains the leader of the pack of the disease-modifying therapies. Those are…

July 20, 2017 News by Patricia Silva, PhD

Ocrevus Is Popular Among Neurologists, but Insurance Is a Growing Concern, Report Concludes

Ocrevus' market introduction is off to a stellar start, with nearly half of neurologists surveyed by Spherix Global Insights saying they are using the therapy — the first ever approved for both relapsing and primary progressive multiple sclerosis. Within six months, 80 percent of neurologists are expected to prescribe Ocrevus, according to a report in the second-quarter edition of RealTime Dynamix: Multiple Sclerosis by Spherix Global Insights. But insurance is having an increasing impact on treatment decisions, the report also found, according to a Spherix press release. More patients are receiving less than optimal care because of inadequate or inferior insurance coverage, and neurologists report that insurers have become more aggressive in managing MS patients. Surveying 104 neurologists in June, the report showed that physicians followed through with their intent — reported in earlier surveys — to prescribe Ocrevus as it became available. With Ocrevus being the first approved drug for primary progressive MS, these patients make up a sizable part of those receiving it. But patients with relapsing forms of MS represent more than half of new users, according to the report. Ocrevus was also, by far, the drug that neurologists had learned most about, and felt most excited about using, the report added. Most of the patients on Ocrevus were switched from Biogen's Tysabri or Rituxan — a drug that, like Ocrevus, is also produced by Genentech/Roche. One in five patients was switched from an oral disease-modifying treatment, mainly Biogen’s Tecfidera (dimethyl fumarate). But for about 25 percent of Ocrevus-treated patients, the drug is the first disease-modifying therapy they have received. The survey also revealed that patients are the driving force behind new Ocrevus prescriptions. Seventy-one percent of neurologists receive requests from patients who want to start the treatment. While neurologists have to turn some of these requests down for various reasons, a large proportion of those who ask for the treatment receive it. Another insight from Spherix’s “RealWorld Dynamix: DMT Brand Switching in MS” survey was that patients' requests for a specific brand are often honored. Seventy-seven percent were prescribed the brand they requested, the survey showed. Interestingly, neurologists believed the number to be lower. Most patients who made a specific request, the report indicated, asked for Tecfidera in the past year and a half. Tecfidera is by far the leading oral disease-modifying drug prescribed in MS. Meanwhile, according to the report, Biogen's Avonex, Bayer's Betaseron, Teva's Copaxone, and EMD Serono's Rebif continue on a downward path. At least 30 percent of neurologists report lower use of these therapies in the past three months. Patients previously on these drugs are mainly switched to oral disease-modifying drugs. But this trend is projected to slow, with only Sanofi-Genzyme's oral Aubagio (teriflunomide) continuing to grow. But the choice of treatment may increasingly be driven by insurance. Compared with the same quarter of 2016 — when neurologists estimated that 14 percent of patients received suboptimal treatment because of poor insurance coverage — 20 percent of patients are now judged to be in this situation. Also, 60 percent of surveyed physicians feel that insurance companies have become more aggressive in MS treatment management. A similar percentage also say that insurance policies influence how they prescribe specific disease-modifying drugs.

July 18, 2017 News by Patricia Silva, PhD

Australian Authorities Approve Ocrevus Following U.S. Endorsement of Breakthrough MS Therapy

Australia has become the first country to approve Genentech's Ocrevus for relapsing and primary progressive multiple sclerosis treatment since the therapy's initial approval by the U.S. Food and Drug Administration in March 2017. The Australian Therapeutic Goods Administration gave Ocrevus the green light on July 17, filling an unmet need for Australia's estimated 23,000 MS patients. “We are pleased that another regulatory body recognized for its rigorous review process has approved Ocrevus with a broad label as a new treatment option for people with relapsing or primary progressive MS in Australia,” Dr. Sandra Horning, Roche’s chief medical officer and head of global product cevelopment, said in a press release. “Approval in Australia is significant because of the high prevalence of MS in the country, making it the leading cause of non-traumatic disability in young adults." The drug's developer, Genentech, and Genentech's parent company Roche have submitted applications to get Ocrevus approved in more than 50 countries in Europe, Latin America and the Middle East. Ocrevus trials showed that, among relapsing patients, relapse rates were nearly halved compared to those treated with Rebif. Many of these patients also reached a level of no disease activity — measures that Genentech has continued to explore after the drug's U.S. approval. In addition, data also showed that PPMS patients, who deteriorate more rapidly, benefit from Ocrevus treatment. “People with PPMS [primary progressive multiple sclerosis], who often experience faster and more severe disability, have not had any approved treatment until Ocrevus," Horning said. "We continue to work closely with regulatory authorities across the world to bring Ocrevus to people with multiple sclerosis as soon as possible." Ocrevus is an antibody that blocks the CD20 molecule on certain immune B-cells. Researchers believe these cells directly damage myelin — the protective coat that insulates nerve cells in the brain and spinal cord. Evidence also indicates that B-cells can directly damage neurons themselves. The drug continues to be evaluated in a range of clinical trials, including one that specifically focuses on how the drug’s B-cell depleting actions play out to harness MS disease processes.

Recent Posts