Disease modifying therapies (DMT)

U.S. neurologists are increasingly prescribing Genentech’s Ocrevus (ocrelizumab) to their multiple sclerosis patients, Spherix Global Insights reports. Another good sign for Genentech is that, in just three months, neurologists have increased by 50 percent their estimate of the numbers of relapsing-remitting MS patients who could benefit from Ocrevus.

Would you be more likely to stick to your MS drug schedule if being diligent lowered the cost of that drug? Biogen, which makes half a dozen MS drugs, including Avonex and Tysabri, seems to be betting that you would. It’s no secret that patients have…

Australia has approved a shorter treatment regimen of Merck’s Mavenclad for relapsing-remitting multiple sclerosis. The Therapeutic Goods Administration authorized 20-day courses of the cladribine tablet form of the medication once a year for two years. The regimen reduces relapse rates and the progression of the disease for up to four years, Merck said. The new approval came after Merck submitted additional clinical trial findings on the therapy. Health Canada and the European Commission approved Mavenclad earlier this year. Merck continues to seek its regulatory approval in the United States and other countries. "Mavenclad will be a welcomed treatment option for patients with the relapsing-remitting form of MS,” Bill Carroll, clinical professor of neurology at the University of Western Australia and the Perron Institute, said in a press release. “As an oral therapy taken in two short courses over a two-year period, Mavenclad will be convenient for all eligible patients in Australia, including those who may not live close to their treating healthcare professional," added Carrol, a neurology consultant at the Sir Charles Gairdner Hospital as well as president-elect of the World Federation of Neurology. Mavenclad targets immune cells that trigger relapsing MS. Multiple sclerosis is an autoimmune disease, or one in which the immune system attacks healthy cells. Mavenclad inhibits harmful immune T- and B-cells without suppressing the entire immune system. Australia based its approval of the drug on the findings of a number of clinical trials, including the Phase 3 CLARITY, CLARITY EXTENSION and ORACLE-MS studies, the Phase 2 trial ONWARD study, and the long-term PREMIERE studies. The trials involved more than 2,700 RRMS patients, some of whom were followed more than 10 years. The trials showed that Mavenclad can significantly reduce relapse rates, disability progression and brain atrophy. Doctors recommended the therapy for patients who failed to respond to, or are unable to tolerate, other MS treatments. "We are pleased the Therapeutic Goods Administration has updated the product Information for Mavenclad in Australia to reflect additional clinical data," said Simon Sturge, chief operating officer of Merck's biopharma business. "Our next step is to work closely with the Australian government to bring this treatment advance to patients as quickly as possible."

Alkermes and Biogen have begun working together on a compound known as ALKS 8700 as a potential treatment for relapsing forms of multiple sclerosis. Under the agreement, Alkermes will be responsible for obtaining regulatory approval of the drug, while Biogen will handle its marketing. ALKS is taken orally. The body quickly transforms it into a compound known as monomethyl fumarate that can counter MS. Aikermes designed it to have better features than Tecfidera (dimethyl fumarate) — in particular, fewer gastrointestinal side effects. The partnership gives Biogen worldwide marketing rights to ALKS 8700. Alkermes will receive a royalty on global sales. Aikermes is evaluating ALKS 8700's safety and effectiveness in what it has dubbed the EVOLVE-MS clinical trial program. It includes two Phase 3 trials that are comparing ALKS 8700 with Tecfidera in patients with relapsing-remitting MS, or RRMS. Preliminary results of the EVOLVE-MS-1 trial, which involved 580 patients, showed few gastrointestinal side effects from ALKS 8700. The most common adverse events in the first month of treatment were flushing, diarrhea, and a rash known as pruritus. Aikermes discussed the treatments safety, and patients' ability to tolerate it, at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris in October. The company is still recruiting participants for a second trial that will compare ALKS 8700 and Tecfidera's effect on the gastrointestinal system. The EVOLVE-MS-2 study will  be conducted at locations in several U.S. states and six sites in Poland. Alkermes expects to release initial findings from the trial in the first half of 2018.  

Immune cells that destroy myelin in multiple sclerosis (MS) access the brain and spinal cord via two different routes, a new mouse study shows. This suggests that therapies which target these entry routes may shield the brains of MS patients from further damage. The study, “Caveolin1 Is Required for…

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.

U.S. nurses and physicians’ assistants prescribe antibody-based disease-modifying therapies to their multiple sclerosis patients more than neurologists do, a survey indicates. The trend has been for the doctors to stick with interferon therapies, the study said. Antibody-based disease-modifying therapies are also known as monoclonal antibodies. They are designed to harness the…

Myelin-producing Brain Cells Regenerated Using Stem Cells in Early Study We know that when the myelin coating of our nerve axons is destroyed, MS symptoms result. So a process that halts or reverses that destruction is the goal of a lot of MS research. This is a…

Merck’s Mavenclad (cladribine tablets) is now a recommended treatment for British adults with highly active multiple sclerosis (MS), following the issuance of a final appraisal determination by the country’s National Institute for Health and Clinical Excellence (NICE). The therapy — given at a dosage of 10 mg — received the…

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.

Have you ever thought about stopping whatever MS treatment you’re using? I have. So has John Corboy. Corboy’s not an MS patient. Rather, he’s a researcher at the University of Colorado’s medical school. And he’s studying whether older patients, if they haven’t had a relapse for several…

#MSParis2017 – Trial to See if Disease-modifying Therapies Not Necessary in Older MS Patients This tops my list this week because, at age 69, I certainly fit the definition of an “older” MS patient. The study is hoping to enroll 300 MS patients in the U.S. who…

The National Multiple Sclerosis Society (NMSS) has officially announced its collaboration with Corrona on the launch of the Corrona Multiple Sclerosis Registry to compare the safety and effectiveness of approved therapies in multiple sclerosis (MS). Corrona, based in Cambridge, Massachusetts, conducts observational cohort studies, offering analytic expertise…

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…

Celgene‘s investigative drug ozanimod has been shown to be more efficient than an intramuscular injection of interferon beta-1a (marketed as Avonex by Biogen) in reducing relapses and disease progression in patients with relapsing multiple sclerosis (MS), according to results of the two-year Phase 3 RADIANCE trial. The findings were…

The Japanese company MediciNova‘s anti-inflammatory agent ibudilast slows multiple sclerosis patients’ brain shrinkage and their loss of the protective myelin coating around nerve cells, a Phase 2 clinical trial shows. Robert J. Fox of Ohio’s Cleveland Clinic Neurological Institute presented the results at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25-28.

A clinical study now enrolling people with progressive or relapsing multiple sclerosis (MS) will examine the feasibility of older patients stopping use of disease-modifying therapies if they have had no relapses for a number of years. John Corboy, with the University of Colorado School of Medicine, presented the study at…

Lemtrada (alemtuzumab) remains a “game-changer” of a treatment for relapsing multiple sclerosis (MS), with benefits continuing and no new side effects seen in a study of its use that now goes out seven years, Aaron Boster, a neuroimmunologist at Ohio Health, said in an interview at the…

While early use of high-efficacy treatments lowers relapse rates among patients with relapsing-remitting multiple sclerosis (MS) compared to lower-efficacy ones, starting these therapies earlier may only impact the accumulation of disability among young patients, according to data presented at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, France. Earlier treatment…

This is a special edition of Multiple Sclerosis News Today's daily Alexa Flash Briefing, covering the latest news from the 7th Joint ECTRIMS-ACTRIMS Meeting currently underway in Paris, France. The MS News today team in on-site at the conference, providing exclusive coverage of the presentations and speakers.

Since the approval of the first disease-modifying drug (DMD) for MS back in the mid-1990s, another dozen or so have been added as treatment options. But, just as MS affects each patient differently, so do the drugs. Missing has been a tool to follow MS patients and their…

Long-term exposure of at least three years of beta-interferon therapies such as Rebif or Avonex may increase the survival of multiple sclerosis (MS) patients, a population-based study suggests. The study reporting the findings, titled “Beta-interferon and mortality in multiple sclerosis: a population-based international study,” was presented Friday at the ongoing ECTRIMS-ACTRIMS Meeting…

Radiologically isolated syndrome (RIS) is a rare and relatively recent condition in which people have multiple sclerosis (MS)-like brain and spinal cord lesions without showing disease activity. But since the establishment of the RIS diagnosis, researchers have not reached an agreement on whether these patients should receive MS disease-modifying therapies.

Sanofi Genzyme‘s Lemtrada (alemtuzumab) and Biogen’s Tysabri (natalizumab) are more effective in preventing conversion to secondary progressive multiple sclerosis (SPMS) compared to older injectable drugs, researchers from the University of Cambridge in the U.K. reported at the 7th Joint ECTRIMS-ACTRIMS Meeting Oct. 25-28 in Paris. The…

There’s been some internet buzz recently about the possibility of an over-the-counter allergy drug that helps to repair the myelin that MS damages. The drug is clemastine fumarate, and I suspect that some of that buzz may have been generated by headlines found on Twitter and…

Inhibiting an enzyme prevented mice from developing a multiple sclerosis-like disease, a European study reports. The finding about HDAC1, a member of the histone deacetylases family of enzymes, could open up new therapy possibilities for MS. Researchers published their study, “A T cell-specific deletion of HDAC1 protects against experimental…

If you have MS, you’ve probably used a specialty drug. My first was Avonex, which I began to use about 1998. Several others followed. There’s no formal definition of a specialty drug, but these therapies have several things in common. First, they’re expensive. According to the vice president in…

Synthon’s prefilled syringe with 40 mg/ml of glatiramer acetate — the generic version of Teva Pharmaceutical’s Copaxone 40 mg — has received regulatory clearance in all 28 member states of the European Union (EU) plus Iceland, Liechtenstein and Norway to treat relapsing-remitting multiple sclerosis (RRMS). The low-dose…

Most multiple sclerosis patients who try Bayer’s BETACONNECT auto-injector stick with their treatment, a study reports. The electronic product may overcome the problem of many patients failing to stick to a therapy  schedule because of what they consider hassles connected with injections. An auto-injector is one that patients can use…

Do you ever stop and ponder the value of MS drugs? I’m not talking about if they work and the ways they improve our lives. I’m thinking of the COST of them and what their pricing means to investors. I get several market analysis reports on the pharmaceutical industry,…