Genentech

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 of multiple sclerosis (MS) patients treated with either therapy, said researchers from the Rocky Mountain MS Center at the University of…

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…

The 7th Joint ECTRIMS-ACTRIMS Meeting, taking place in Paris this month, is one of the largest scientific conferences focused solely on multiple sclerosis (MS), and the National Multiple Sclerosis Society will be among the many interested parties attending. To get a feeling for meeting highlights and presentations the…

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.  

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.

Probiotics Consumption May Improve Certain Disease Parameters in MS Patients, Study Suggests Probiotics (bacteria that help move food through your gut) have been used for years to help treat stomach disorders such as irritable bowel syndrome, inflammatory bowel disease, and some types of diarrhea. More recently, researchers have…

Ocrevus (ocrelizumab) is a less expensive treatment option for relapsing multiple sclerosis (MS) than subcutaneous interferon beta-1a (Rebif) in the long-run, according to a cost-effectiveness analysis published in the Journal of Medical Economics. In addition to lower total costs over a 20-year period, the analysis suggested that Ocrevus…

Five clinics in the Washington area that specialize in administering intravenous and injected treatments to people with chronic diseases are now offering the new multiple sclerosis therapy Ocrevus (ocrelizumab). Arise Infusion Therapy Services said its staff is helping patients manage the authorization process that many insurers require before agreeing to cover…

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.

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.

Genentech shared new insights into the workings of Ocrevus (ocrelizumab) and its effectiveness in reducing disease activity and slowing progression in relapsing and primary progressive multiple sclerosis (MS) at the recent 3rd Congress of the European Academy of Neurology (EAN). The new findings, previously reported here, built on analyses of information gathered during the three Phase 3 clinical trials assessing Ocrevus' safety and efficacy, as well as through monitoring patients in extension studies. The studies showed that nearly 40 percent of Ocrevus-treated relapsing patients and nearly 30 percent of primary progressive patients achieved NEPAD during the Phase 3 trials. In contrast, only 21.5 percent of those treated with Rebif and 9.4 percent receiving placebo achieved NEPAD — figures that demonstrate Ocrevus’ impact on patients’ lives, as well as Ocrevus’ ability to slow the decline in walking ability and other types of disabilities are comparable between patients with relapsing and primary progressive disease — data that demonstrate that the treatment acts on disease mechanisms that drive disability in both disease forms. How these effects play out in the long-term is the subject of ongoing research, as Genentech continues to follow these patients in an extension study. In addition, Ocrevus' prescription label strongly advises against pregnancy while on the treatment. Despite precautions, some women became pregnant during the trials. One of the meeting presentations narrated outcomes of these pregnancies; one healthy baby born at term and two ongoing pregnancies in women exposed to the drug. But while Genentech monitors women who become pregnant while on Ocrevus, the number of reported pregnancies is too small to draw conclusions about the treatment’s safety in pregnancy, and researchers do not know if Ocrevus also depletes B-cells in the fetus or in the baby born to a treated woman.

Ocrevus (ocrelizumab) significantly reduces disease activity and disability progression in patients with relapsing multiple sclerosis (MS) and primary progressive MS (PPMS), according to results of post-hoc analyses of Genentech’s Phase 3 clinical trial program assessing the drug.

Stephen L. Hauser, MD, director of the University of California, San Francisco (UCSF)‘s Weill Institute for Neurosciences, has been awarded the 2017 Taubman Prize for Excellence in Translational Medical Research. Recognized for scientific work that challenged the way multiple sclerosis (MS) is regarded, Hauser’s discoveries have opened new therapeutic…

Already an approved treatment for relapsing and primary progressive multiple sclerosis (MS), Ocrevus (ocrelizumab) is still undergoing scrutiny in several clinical trials. Most focus on the drug’s effects in specific patient groups, but one study aims to advance understanding of how Ocrevus works to harness disease. To do so, the open-label Phase 3…

Ocrevus (ocrelizumab), a recently approved therapy for relapsing and primary progressive multiple sclerosis (MS), is now on the U.S. market, but research into its use is far from over. Several clinical trials, sponsored by Ocrevus’ developer Genentech or its parent company Roche, are looking at various aspects of the treatment. Multiple Sclerosis…

Multiple sclerosis patients who benefited from Ocrevus (ocrelizumab) 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, “Preliminary Results of the OPERA I and…

Genentech has rolled out a website to connect multiple sclerosis (MS) patients and caregivers with resources that can help them. The company unveiled GatherMS at the annual meeting of the Consortium for Multiple Sclerosis Centers in New Orleans. The event started May 24 and will end May 27. Genentech created GatherMS…

A multiple sclerosis (MS) patient treated in Germany with Ocrevus (ocrelizumab) has developed the dreaded brain infection progressive multifocal leukoencephalopathy (PML). But it is not clear whether the recently approved Genentech/Roche-developed treatment is the cause. The patient took the last dose of a three-year course of Tysabri (natalizumab) in February. Tysabri is…

Recently approved, Ocrevus (ocrelizumab) should now be available nationwide for patients prescribed the therapy. But as with any new treatment, concerns about safety and practical issues are on many patients’ minds. Multiple Sclerosis News Today asked Dr. Jack Burks — a neurologist and researcher who serves as chief…

A multiple sclerosis (MS) trial now underway in Colorado is assessing the safety and tolerability of switching from Rituxan (rituximab) to Ocrevus (ocrelizumab), and its lead investigator, Dr. Timothy L. Vollmer, largely expects no problems. The neurologist believes the two Genentech therapies — both antibody-based drugs that target the CD20 molecule on B-cells —…

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-based Genentech and its Swiss parent…

While many multiple sclerosis patients celebrated the recent approval of Ocrevus (ocrelizumab), others argued that the drug is largely a rebranded version of rituximab. Rituximab — sold as Rituxan for indications like non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis — is used off-label to treat relapsing MS. In online forums and social media,…

Genentech, Novartis and Sanofi Genzyme are sponsoring this year’s Walk MS, an annual event to raise funds for multiple sclerosis (MS) and the National Multiple Sclerosis Society (NMSS). Genentech, a division of Roche, returns as an MS Walk sponsor for the second year and will promote the “MS Voice”…

Ocrevus (ocrelizumab), now approved for both relapsing and primary progressive multiple sclerosis (MS), is expected to become available in the coming week. While patients and neurologists are waiting, Multiple Sclerosis News Today spoke to Genentech about the treatment’s approval, future research plans, and what patients can expect in terms…

With the recent approval of Ocrevus (ocrelizumab) for both primary progressive and relapsing multiple sclerosis (MS), interest in the medication is peaking. To help readers of Multiple Sclerosis News Today better understand this new medication and how it works, as well issues dealing with access, use, and potential side effects, here is a summary…

American patient groups and neurologists have clearly been giving Ocrevus (ocrelizumab) plenty of attention since news of its approval landed, as a sweep of U.S. reaction to the FDA’s decision showed. But what is happening elsewhere in regard to this first treatment for both primary progressive and relapsing multiple sclerosis (MS)?…

The historic approval of Ocrevus (ocrelizumab), the first-ever treatment for primary progressive multiple sclerosis (MS), set off ripples in the relatively calm waters of MS news reporting. The drug, which was also approved Tuesday as an unusually effective and safe treatment for relapsing MS, is viewed as a game-changer…

At long last, and for the first time in medical history, people 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)  as a disease-modifying therapy for both forms of MS, a chronic autoimmune disease.

Twenty years ago, the idea that B-cell depletion could treat multiple sclerosis would have been greeted with a hearty laugh by any well-respected neurologist or MS researcher — or perhaps a scoff. But times change and research advances. Today, a medicine that gets rid of certain B-cells may be the most powerful drug yet developed against…

The potential approval of Ocrevus (ocrelizumab) this month supports the idea that, someday, a world free of multiple sclerosis (MS) is possible, according to Dr. Tim Coetzee, the National Multiple Sclerosis Society’s chief advocacy, services and research officer. While Coetzee — and the society he represents — realize the potential of…