August 25, 2020 News by Patricia Inacio, PhD Mavenclad Effectively Lowers Relapse Rates, Study Comparing DMTs Finds MavencladĀ (cladribine) appears to be better at lowering relapse rates during the first two years of disease in relapsing-remitting multiple sclerosis (RRMS) patients than other MS therapies, including interferon, Copaxone (glatiramer acetate) and Tecfidera (dimethyl fumarate), a head-to-head observational study found. Mavenclad, however, was less effective at…
August 10, 2020 News by Patricia Inacio, PhD 1 in 5 MS Patients Don’t Adhere to Daily Oral DMTs, Real-world Study Finds About 20%, or 1 in 5,Ā multiple sclerosis (MS) patients fail to adhere to oral disease-modifying therapies (DMTs) taken each day, and about 1 in 4 stop using a prescribed daily oral treatment within one year, a study based on reported real-world use found. The study āReal-world adherence to,…
July 29, 2020 News by Marisa Wexler, MS Canadian MS Working Group Updates Guidelines for Diagnosis, Treatment The Canadian MS Working Group (CMSWG) ā made up of neurologists with the Canadian Network of MS ClinicsĀ ā has updated its recommendations concerning diagnosis and the use of disease-modifying therapies (DMTs) for multiple sclerosis (MS), according to a press release from theĀ MS Society of Canada.
July 7, 2020 News by Marta Figueiredo, PhD Study: Mavenclad Shows Long-term Effectiveness at Preventing MS Relapses, Disease Progression MavencladĀ (cladribine) prevents relapses and disease progression in more than half of patients with relapsing forms of multiple sclerosis (MS) for at least five years after the last dose, according to a real-life study from Italy. These findings, based on real-world data from Italian MS patients previously treated…
June 15, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: Myelin, Mavenclad, Online Stress Relief, Rehab Aids Note: A story mentioned in this column, āPrime Signs Agreement With EMD Serono to Improve Mavencladās Cost-benefit Value,ā was updated on June 15, 2020, to clarify that the agreement allows for possible reimbursement for Primeās health plan clients, not patients…
June 10, 2020 News by Joana Carvalho, PhD Prime Signs Agreement With EMD Serono to Improve Mavencladās Cost-benefit Value Note: This story was updated on June 15, 2020, to clarify that the agreement allows for possible reimbursement for Prime’s health plan clients, not patients directly.Ā Prime Therapeutics has signed an agreement with EMD Serono that may provide financial compensation for its health plan clients if their members…
April 14, 2020 News by Marta Figueiredo, PhD Ocrevus Use Still Growing in Europe But Challenges on Horizon, Spherix Reports Prescriptions ofĀ RocheāsĀ OcrevusĀ (ocrelizumab) among multiple sclerosis (MS) patients initiating or switching aĀ disease-modifying therapy (DMT) continue to rise in Europe, according toĀ a surveyĀ conducted byĀ Spherix Global Insights. Ocrevus, an anti-CD20 monoclonal antibody administered directly into a vein,Ā was approved in the European UnionĀ to treat active forms…
February 10, 2020 News by Marisa Wexler, MS Mavenclad May Be Added to RRMS Treatments on Quebec’s Public Health Plan The agency in charge of health and social services for Quebec, known as theĀ Institut national d’excellence en santĆ© et en services sociaux (INESSS), is recommending thatĀ Mavenclad (cladribine) be offered at discount to adults with relapsing-remitting multiple sclerosis (RRMS) enrolled in the province’s health system. INESSS’ opinions…
December 16, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: US Patent for Remyelination Therapy, Tysabri and Inflammation, Canada Funding Mavenclad MetP Pharma Awarded US Patent for Potential Remyelination Therapy Mention remyelination and the reaction from most of us with multiple sclerosis is probably, “How soon?” This announcement makes me hope that it’s now a little sooner. The process combines testosterone with a compound that changes the activity of something…
December 13, 2019 News by Iqra Mumal, MSc EMD Serono, Canada Sign Agreement for Public Health Plan Funding of Mavenclad for RRMS People with relapsing-remitting multiple sclerosis (RRMS) across Canada are a major step closer to having access to EMD Seronoās Mavenclad (cladribine). EMD Serono, known as Merck KGaA outside of North America, has finish negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA)Ā that oversees new drugs coming in,…
November 22, 2019 News by Ana Pena PhD Ocrevus Top Choice of US Neurologists for Active SPMS, But Mayzent and Mavenclad Gaining Interest, Report Says Genentech‘sĀ OcrevusĀ (ocrelizumab) continues to be the most prescribed medication to reduce inflammatory disease in people with active secondary progressive multiple sclerosisĀ (SPMS) amongĀ U.S. neurologists, even though Novartis’Ā MayzentĀ (siponimod) and EMD Serono’sĀ MavencladĀ (cladribine) were approved in March to treat this same MS…
November 15, 2019 News by Grace Frank CHMP Favors Mayzent as Oral Treatment Specifically for Active SPMS Patients in EU The Committee for Medicinal Products for Human Use (CHMP) issued an opinion supporting MayzentĀ (siponimod) as an oral treatment specifically for adults with active secondary progressive multiple sclerosisĀ (SPMS) in the European Union. Opinions released by CHMP, an arm of the European Medicines Agency (EMA), carry weight and are…
October 14, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Mavenclad and Ocrevus Use Rising in EU, Ampyra Patent Appeal Denied, Exercise and MS Pilot Study Mavenclad, Ocrevus Use Rising in EU as Injectables and Tysabri Decline, Spherix Reports I’m not surprised at reports that the use of Mavenclad (cladribine) and Ocrevus (ocrelizumab) is increasing in Europe, or that the use of injectable disease-modifying therapies appears to be declining there. Mavenclad and Ocrevus are approved…
October 11, 2019 News by Ana Pena PhD Mavenclad, Ocrevus Use Rising in EU as Injectables and Tysabri Decline, Spherix Reports Prescriptions of two multiple sclerosisĀ (MS) treatments ā Ā Merck KGaA‘s Mavenclad (cladribine) and Roche‘s Ocrevus (ocrelizumab) ā have been rising in Europe over the past six months, bolstered by greater market access and compassionate use programs, according to a survey of 250 EU neurologists run…
September 23, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Ozanimod, Achtar Gel, Onset Age Progression Link, Glial Cells Could Differentiate MS Types In this column, I take a look at more exciting research from the ECTRIMS2019 conference this month. #ECTRIMS2019 ā Ozanimodās āKey Advantagesā May Lead to New First-line MS Therapy: Interview with Neurologist Jeffrey Cohen This year we’ve seen the approval of two new multiple sclerosis treatments in the United…
September 20, 2019 News by Ana Pena PhD #ECTRIMS2019 – Ahead for Mavenclad: Fuller Understanding of What Makes It ‘Unique,’ Serono Exec Says in Interview Real-world data continues to support the safety and effectiveness ofĀ MavencladĀ (cladribineĀ tablets) in treating multiple sclerosis (MS), and several studies underway will help scientists gain in-depth understanding of how Mavenclad works, its impact on the immune system, and the durability of its benefits, an executive with EMD SeronoĀ said in an…
August 28, 2019 News by Jose Marques Lopes, PhD Mavenclad Cost-Effective Treatment for At-risk RRMS Patients Compared to Other DMTs, Dutch Study Finds Treating at-riskĀ relapsing-remitting multiple sclerosis (RRMS) patients is most cost-effective withĀ MavencladĀ (cladribine) tablets when compared to Gilenya (fingolimod), Lemtrada (alemtuzumab) or Tysabri (natalizumab),Ā according to a study in Dutch patients. The study, āCost Effectiveness of Cladribine Tablets for the Treatment of Relapsing-Remitting Multiple Sclerosis in…
August 16, 2019 News by Marisa Wexler, MS MS Therapies Among Limited Offerings Through AllianceRx Walgreens Prime Medications for treating certain rare and chronic conditions, Ā including multiple sclerosis (MS), are now available from the specialty and home delivery pharmacy AllianceRx Walgreens Prime, the company announced. The newly included specialty medications are all limited distribution drugs (LDDs), which means the drug manufacturers have signed agreements giving very…
July 23, 2019 News by Patricia Inacio, PhD Gilenya Approved in China for Adults and Children with Relapsing MS Gilenya (fingolimod) has been approved in China as a disease-modifying therapy to treat adults and children, ages 10 and older, with relapsing forms of multiple sclerosis (MS). Gilenya,Ā marketed byĀ Novartis, is an oral disease-modifying treatment for relapsing MS. It acts by binding and modulating receptors…
July 17, 2019 News by Ana Pena PhD Phase 3 Trial of Ibudilast Planned for SPMS Patients with Inactive Disease, MediciNova Says A Phase 3 trial is planned to confirm the safety and efficacy of oral ibudilast (MN-166) in treating people with secondary progressive multiple sclerosis (SPMS) without relapses, or those whose disease is not active, MediciNovaĀ announced. Data from this single Phase 3 study may be used to request…
July 8, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Botox for Kids, Kids’ Healthcare Needs, Mavenclad, MS Fatigue Diet FDA Approves Botox to Treat Upper Limb Spasticity in Children Aged 2 to 17 Botox injections have been approved to treat spasticity and bladder problems in adults with multiple sclerosis (MS) for years. It’s encouraging to see pediatric-onset MS receiving more attention and approval for medications. As MS is…
July 2, 2019 News by Ana Pena PhD Neurologists Prefer Mayzent for SPMS and RRMS, But Mavenclad Could Be ‘Ideal’ First Switch, Report Suggests While neurologists favor Novartis‘ Mayzent (siponimod) for people with active secondary progressive multiple sclerosis (SPMS) and transitioning relapsing-remitting MS (RRMS), EMD Serono‘s Mavenclad (cladribine) could serve as a first option for patients with RRMS who failed initial therapy, Spherix Global Insights says in its…
June 28, 2019 News by Joana Carvalho, PhD Mavenclad Continues to Demonstrate Sustained Efficacy, Safety in Patients with Relapsing Forms of MS, Post-hoc Analyses Show Mavenclad (cladribine) tablets continue to show sustained efficacy and consistent safety in patients with relapsing forms of multiple sclerosis (MS), post-hoc analyses of a Phase 3 trial extension study show. The findings are set to be presented in several posters during the 5th Congress of the European…
June 3, 2019 News by Joana Carvalho, PhD Mavenclad May Surpass Gilenya as DMT of Choice for Treatment of MS in Canada Mavenclad (cladribine) may surpass Gilenya (fingolimod) in the category of oral disease-modifying therapy (DMT) of choice for the treatment of multiple sclerosis (MS) in Canada, according to a press release. The Canadian healthcare market for MS has grown considerably over the past two years. In November…
April 22, 2019 News by Jose Marques Lopes, PhD Two-year Efficacy with Short-course Treatment Sets Mavenclad Apart, EMD Serono Executive Says Mavenclad (cladribine) tablets stand out as a treatment for relapsing forms ofĀ multiple sclerosisĀ (MS), providing two years of proven efficacy with a maximum of 20 days of oral treatment,Ā a top executive with EMD SeronoĀ says. After being approved in more than 50 countries worldwide, including theĀ European Union,Ā Australia,…
April 18, 2019 Columns by Jennifer (Jenn) Powell The DMT Decision: Tried and True or Shiny and New? I spend a great deal of time in my head. I think. A lot. Perhaps I do so more than I should, but then again, it is a haven at times. My thoughts run the gamut from the serious to the inane. Today my thoughts…
April 3, 2019 News by Marisa Wexler, MS Cleveland Clinic Neurologist Applauds Mayzent’s FDA Approval, But Surprised by Those It May Not Treat When theĀ U.S. Food and Drug Administration approvedĀ the disease-modifying therapy Mayzent forĀ relapsing types of multiple sclerosis, itĀ specified in its label that the treatment was for people withĀ clinically isolated syndrome, relapsing-remitting MS, and ā importantly āĀ secondary progressive MSĀ provided they have "active" disease. The approval is good news, an MS researcher and physician saidĀ toĀ Multiple Sclerosis News TodayĀ in an interview, but "surprising" in that the FDA's decision was largely based on a trial that didn't involve CIS patients and wasn't focused on responses among particular types of SPMS. āIt's the first time that I've seen in the MSĀ field that regulatorsĀ made an approval designation ā activeĀ secondary progressive MS ā based on an underpowered subgroupĀ analysis,ā saidĀ Robert Fox, MD, a neurologist at the Mellen Center for Multiple Sclerosis at the Cleveland Clinic. Novartis'Ā medication, as a first oral therapy approved in the U.S. forĀ a form ofĀ SPMS,Ā is a big step forward in MS treatment, he said. But details of the FDA's decisionĀ caughtĀ him off guard. Fox served on the steering committee for the EXPAND Phase 3 clinical trial ,Ā on which the FDA decision was largely based.Ā His clinic was also one of the sites treating and evaluating patients in this pivotal study. Results of the EXPAND trial showed thatĀ Mayzent could reduce the risk of disability progression at three months (the trialās primary endpoint, or goal) by 21% in treatedĀ SPMS patients, compared to those given aĀ placebo. Among those with active SPMS (meaning with relapses), a 33% reduction was observed. The treatment, an S1P modulator that works in part to keep lymphocytes from entering the brain to trigger inflammation,Ā alsoĀ decreased the annualized relapse rate by 55% and improved cognitive processing speed in all treated patients.Ā āWhat was found, and I think quite clearly found in a large-size study, was that siponimod in patients with secondary progressive MS clearly slowed the progression of clinical disability over the course of the trial,ā Fox said. āIt's a statistical concept ā obviously patients either progress or they don't progress ā but on an overall basis there was a 21% slowing in the rate of progression of clinical disability.ā The FDAās decision is particularly important for SPMS patients. While Ocrevus (ocrelizumab) alsoĀ treats all relapsing MS forms and people with primary progressive disease (PPMS), it's an intravenous therapy given every six months. Mavenclad (cladribine), approved for relapsing patients in the U.S. just days after Mayzent, is another oral and active disease therapy. To Fox, Mayzent seemed to reach beyond only those secondary progressive patients with clinically active disease. āReally, this is the only drug that's been found to be effective in secondary progressive MS," he said. āTo that degree, it stands alone.ā That's why two points in the FDA's decisionĀ surprised him. The firstĀ is the label's specific mention of clinically isolated syndrome. CISĀ is defined asĀ theĀ first clinical presentationĀ of this diseaseĀ ā aĀ neurological episode that lasts at least 24 hours, and is characterized by inflammatory demyelination (the loss of myelin, the protective coat surrounding neurons). Ā For clinicians like Fox, CIS is a first manifestation of MS ā a kind of "mono sclerosis."Ā Since thereās only one documented attack, it canāt yet be considered multiple sclerosis, āas the multiple hasn't happened,ā Fox said, but many "in the field consider CIS to be ā¦ an early stage of MS." āIf the patient has a whole bunch of lesions on their brain [as seen on an MRI scan] and they had a single clinical event, ah, probably, they have MS,ā he said. Regulatory bodies like the FDA,Ā however,Ā have historically considered CIS to be its own separate entity. That makes this decision doubly surprising, according to Fox, since the EXPAND trial only enrolled patients with SPMS, not CIS. Ā āIt's the first time I've seen them approve for CIS specifically when there wasn't a trial in CIS,āĀ Fox said. āI agree with it ā I don't have a problem with it ā it just surprised me that the regulators were so progressive in their appreciation of MS.ā The second ā and far more unsettling ā surpriseĀ wasĀ the FDAās decision toĀ only approve Mayzent for āactiveā SPMS patients, instead of all SPMS patients. This decision didnāt come out of nowhere, he noted, but it remains puzzling in the context of the EXPAND trial.Ā InĀ compiling trial results, investigators did a subgroup analysis ā as they often do, almost as an aside for research reasons ā and found more favorableĀ responses to Mayzent treatmentĀ in patients with active inflammation beforeĀ the trial's start, those it determined to be with "active" disease. Ā āThere was a third of patients who had a relapse in the two years prior to enrollment, and those patients actually had a 30% slowing in disability progression, compared to the 21% overall,ā Fox said. This certainly does suggest that Mayzent can be more effective in people with active disease ā but there's a catch. The trial itself was not designed to make such a distinction. It enrolled SPMS patients regardless of activity, and its priority goal was changes in disease progression across all who were treated with Mayzent or given a placebo. Ā āWhat's important is that the trial was powered for the overall outcome. It was not powered for subgroup analysis,ā Fox said,Ā considering this a crucial point.Ā In clinical studies, being āpoweredā refers to theĀ enrollingĀ of whatever specific number of participants a study needs to ensureĀ itsĀ results will reach statistical significance. More people are redundant and, as such, an unnecessary cost; fewer could mean that trial's conclusions cannot be supported by rigorous scientific measures.Ā In other words, Fox said, the only conclusions that can be drawn from the EXPAND study reliably ā with rigor ā are based on data drawn from all its SPMSĀ patients, not aĀ subgroup with active disease. This trial āfollowed over 1,600 patients for the clinicalĀ disability. These are purposely powered so that you're not following twice as many people as you need toĀ ā¦ you're powered for that primary outcome,ā he said. āSo, how could they [the FDA] look at a subgroupĀ analysis and make an approval decision based on a subgroupĀ analysis that was underpowered?ā The neurologist gave as examplesĀ other subgroup differences found in trial analyses that didn't affect regulatory approval ā but to his mind, equally could have.Ā One was an analysis findingĀ female SPMS patients respondedĀ to the therapy better than males,Ā showing lesser disease progression. "So why didn't they just approve it for the females and not the males?" Fox asked. But, when asked, Fox did not think the labelĀ toĀ necessarily be an error. "My point is the absurdity of it," he said. "How could they make the regulatory approval based on a subgroupĀ analysis that wasn't powered for conclusions?" He was also particularly troubled becauseĀ the FDAĀ ādidn't define what āactiveā means āĀ is it just a relapse, or is it MRI disease activity?"Ā For many clinicians, āactiveā SPMS refers to ongoing inflammation that can be observed on MRI (magnetic resonance imaging) scans. In EXPAND, however, the active subgroup was defined as patients with clinical relapses within two years of being enrolled in the trial. Fox worries about this apparent lack of a regulatory definition of "active" SPMS, since āobviously, the insurance companies are going to seize upon that, and they're going to look for every way they can to avoid covering it for patients.ā Mayzent, Fox agreed,Ā is likely to be expensive. The therapy is reported to carry a U.S. list price ofĀ $88,500 a year. āI always have a concern about the cost of these drugs. They're all fearfully expensive,ā he said, noting he treats SPMS patients. His focus now is on working to ensure that possible regulatory and financial hurdles wonāt pose too much of an obstacle for patients, especially those with SPMS. āI don't know what the insurance companies are going to do with this, but I'm hoping that it is available for my patients, and I say that as their clinician,ā Fox concluded.
April 1, 2019 News by Joana Carvalho, PhD FDA Approves EMD Serono’s Mavenclad as Treatment for RRMS and Active SPMS The U.S. Food and Drug Administration (FDA) has approved Mavenclad (cladribine) tablets for the treatment of adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS (RRMS) andĀ active secondary progressive disease (SPMS). Up to 85 percent of people with MS are initially diagnosed…
January 11, 2019 News by Alice MelĆ£o, MSc Mavenclad Approved for Reimbursement as RRMS Treatment in Australia Australia was one of the first countries to approve the use of Mavenclad (cladribine tablets, 10 mg) to treat patients with highly active relapsing-remitting multiple sclerosis (RRMS).Ā Now, the countryās government has taken another step to ensure this 20-day course treatment is available to the largest number possible of people affected by the disease. Australiaās Prime Minister, Hon. Scott Morrison MP, announced that Merck KGaAās therapy was included on the Pharmaceutical Benefits Scheme (PBS) listing effective Jan. 1. This will make Mavenclad affordable for about 6,200 patients each year who are already accessing PBS-subsidized medicines for MS. (Of note, Merck KGaA is known as EMD Serono in the U.S. and Canada.) This was made possible by the joint effort of MS Australia, MS Research Australia, clinicians and members of the MS community who, after successive submissions, achieved a positive recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) to list Mavenclad on PBS as a treatment for RRMS. Australia's government will cover almost all costs of Mavenclad, which will mean that patients will have to pay only $40.30 per prescription, or $6.50 for concessional patients. āThanks to our strong economic management, weāve ensured that every new, essential medicine recommended for listing by the Pharmaceutical Benefits Advisory Committee receives government subsidy to make it affordable for all Australians,ā the Prime Minister said in a press release. Mavenclad was developed to target immune T- and B-cells that trigger relapsing MS without suppressing the entire immune system. To be taken for a maximum of 20 days over two years, the oral drug has shown it helps MS patients remain relapse-free for up to four years, while supporting the āresetā of the immune system. Australia's regulatory agency decided to approve Mavenclad based on the findings of a number of clinical trials, including the Phase 3 CLARITY (NCT00213135), CLARITY EXTENSION (NCT00641537), and ORACLE-MS (NCT00725985) studies, as well as the Phase 2 trial ONWARD study (NCT00436826), and the long-term PREMIERE (NCT01013350) trials. These clinical studies involved more than 2,700 RRMS patients, some of whom were followed for more than 10 years. Overall, the trials showed that Mavenclad significantly reducedĀ relapse rates, disability progression, and brain atrophy. Doctors recommend the therapy for patients who failed to respond to, or are unable to tolerate, other MS treatments.
October 29, 2018 News by Alice MelĆ£o, MSc Mavenclad Named ‘Rapid Uptake Product’ in UK with Goal of Speeding Its Availability in NHS Mavenclad (cladribine tablets, 10 mg) was one of the seven medicinal and medical technology products selected by the Accelerated Access Collaborative (AAC) as a “rapid uptake product” ā a U.K. recognition that aims to bring life-changing technologies into the country’s National Health System (NHS), and to patients,…