Ocrevus

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.

Editor’s note: This column is second in a series. Read the first part here. Just you wait! How many times have we heard those words or said them to someone else? I find that now it’s my turn to wait. What I’m waiting for is six months…

In case you missed them, here are some news stories that appeared in MS News Today that caught my eye over the past week. Younger MS Patients Who Are Hospitalized May Be at Higher Risk of Quitting Treatment, Study Reports   Why would young patients, whose MS is…

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.

I’ve done it! I made the treatment switch that so many people with multiple sclerosis are talking about: I said goodbye to Tysabri (natalizumab) and am now on Ocrevus (ocrelizumab) as my disease-modifying therapy (DMT). I went through 56 monthly infusions (or maybe more, I’ve…

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.

Several months ago, I wrote a column about Andrew Barclay. Barclay died in an assisted suicide in December. He’d had multiple sclerosis for many years. Colin Campbell is a 56-year-old MS patient who lives in Inverness, Scotland. He also wanted to die. In fact, he was scheduled…

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…

In case you missed them, here are some news stories that appeared in MS News Today that caught my eye over the past week. Ocrevus Phase 3 Trial Will Explore How Treatment Works by Viewing Changes in Spinal Fluid This new clinical study will try to…

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…

The recent annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC) brought researchers and healthcare professionals to New Orleans to discuss advances — and obstacles to advances — in multiple sclerosis (MS) research. Clinical trials, preclinical studies, basic research, and health interventions were among the May meeting’s focus. Multiple Sclerosis News…

Relapse after First Lemtrada Course No Indication of Poor Long-Term Outcome, Study Finds Some MS patients being treated with Lemtrada report new exacerbation after they complete round one of the drug, and they wonder if this means the drug isn’t working.

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…

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…

In case you missed them, here are some news stories that appeared in MS News Today that caught my eye over the past week. Ocrevus Market Entry Already Changing Dynamics in MS Treatment Choices, Spherix Analysis Suggests   Are pills, shots, or infusions the therapy…

Multiple sclerosis (MS) patients are largely moving away from injectable drugs and towards oral treatments when they switch from first to second-line MS therapies. But that might change with the introduction of Ocrevus (ocrelizumab), which has become the drug of choice for many neurologists advising patients on drug switches. The real-world analysis by…

In case you missed them, here are some news stories that appeared in MS News Today that caught my eye over the past week. MSAA’s Dr. Jack Burks Responds to Readers’ Questions About Ocrevus and Its Use All over the internet MS patients are asking questions about…

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…

The MS Wire is adding a third weekly item, beginning today. It’s a list of several news items that appeared in MS News Today over the preceding week and that caught my eye. Axim Signs Deal to Advance Clinical Trials of Cannabis-based MedChew Rx Gum to…

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 —…

Pamela Arterbridge noticed something was wrong back in 2013 when she woke up one morning, and her legs and feet were tingling. Two years later, Lorraine Lee knew she had a problem when her right leg became extremely fatigued after every workout. Neither realized their eventual diagnosis would be multiple…

Lemtrada (alemtuzumab) may be more effective in preventing relapses in multiple sclerosis patients than the newly approved Ocrevus (ocrelizumab), according to a study presented April 28 at the American Academy of Neurology (AAN) 2017 Annual Meeting in Boston. The study, supported by Sanofi Genzyme and Bayer HealthCare Pharmaceuticals, compared…

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…

New data on the recently approved multiple sclerosis (MS) drug Ocrevus (ocrelizumab) will be presented at the upcoming American Academy of Neurology (AAN) Annual Meeting 2017, which will take place April 22-28 in Boston. The meeting is the first scientific conference focusing on neurology since the U.S.

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,…

It’s been less than a month since Ocrevus was approved by the FDA, and the buzz hasn’t died down. Though there is some trepidation, the MS community is incredibly excited about what the new “game-changing” medication can do for patients all across the country. Here are just a few…

Pamela Arterbridge is one of 70 people at Ohio State University’s Multiple Sclerosis Center taking part in the open-label part of a clinical trial for ocrelizumab, now best known as Ocrevus.  She is a patient of Dr. Michael Racke, who is a pioneer in the field of B-cell treatments for MS,…

Texas firefighter Wayne Donovan is among the estimated 250,000 to 350,000 Americans with multiple sclerosis (MS). He enrolled in a clinical trial testing Ocrevus (ocrelizumab), which the  U.S. Food and Drug Administration recently approved as the first therapy for both relapsing and primary progressive forms of MS. Donovan was diagnosed in 2011 at…

With last month’s approval of the multiple sclerosis drug Ocrevus, I’ve again heard the plea “But how can I afford it?” Ocrevus carries a price tag of about $65,000 a year. That’s not high compared to some other MS drugs, but it still can mean a higher…