CLARITY

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…

#EAN2018 – MavencladĀ Greatly Reduces Risk of RRMS Relapse, Analysis Finds

New retrospective analysis of the Phase 3 CLARITY study (NCT00213135)Ā shows that treatment with MavencladĀ (cladribine tablets) improved annualized relapse rate and magnetic resonance imaging (MRI) outcomes in patients with relapsing-remitting multiple sclerosis (RRMS), regardless of their age. Moreover, the effectiveness of Mavenclad was comparable to five standard therapies…

#AAN2018 – CladribineĀ Injections Deplete Number of Memory B-cells in RRMS, Study Shows

CladribineĀ treatment leads to a selective depletion of memory B-cells in patients with relapsing-remittingĀ multiple sclerosisĀ (RRMS), researchers report. The results are in the presentation ā€œCladribine for the Effective Control of Multiple Sclerosis via Memory B Cell Depletionā€ being given Friday, the final day of the 2018 Annual MeetingĀ of theĀ …

Merck Extension Study Confirms Mavencladā€™s Long-term Benefits in Relapsing MS Patients

Three-fourths of relapsing multiple sclerosis patients who took two short courses of Mavenclad over two years remained relapse-free for four years, according to newly published data from the medication's Phase 3 extension trial. Moreover, patients who took Mavenclad during the first two years and then a placebo for the next two years fared similarly to those who took Mavenclad for the entire four-year period. The European Commission on Aug. 25 approved Mavenclad ā€” developed by Merck KGaA (known as EMD in North America) ā€” to treat relapsing forms of MS in Europe. It based that approval on data from the Phase 3 CLARITY, CLARITY EXTENSION, and ORACLE-MS trials, as well as the Phase 2 ONWARD trial, and the ongoing long-term PREMIERE study. Besides showing the long-term impact of two short courses of Mavenclad ā€” patients took tablets for a maximum of 20 days over two years ā€” this latest study showed that continuing treatment into the third or fourth year offered no additional benefits. This finding supports Merckā€™s earlier studies, which suggested that Mavenclad resets the immune system. This is a stark contrast in treatment approach to most approved MS drugs which work by suppressing either T- or B- immune cells over the long term. Researchers also deemed safety to be similar in the two groups. Most adverse events were mild or moderate, and most patients who had their B-cells and T-cells depleted in the first part of the study had normal, or nearly normal, levels at the end of the extension. Shingles were most common in patients who received the highest cumulative dose of the drug, affecting 4.8 percent of participants. But in the remaining treatment groups, rates of the viral infection were similar at 1.1 to 2 percent, researchers said. Besides Merck's own studies, an independent study recently demonstrated that Mavenclad also improves patientsā€™ quality of life. As such, the company plans to file regulatory approval for Mavenclad in the United States and elsewhere.

Mavenclad Improves Relapsing MS Patientsā€™ Quality of Life, Independent U.K. Study Finds

Merckā€™s Mavenclad tablets significantly improve quality of life among relapsing multiple sclerosis patients while reducing the number of relapses, according to new analyses of previously unpublished data from clinical trials assessing the drug. This new data, published in the Multiple Sclerosis Journal, come just as the European Commission ponders whether to approve the once- rejected therapy to treat relapsing forms of MS. Its decision is expected later this month, seven years after a perceived increased of cancer risk led the European Medicines Agency (EMA) to block Mavenclad. In 2011, the U.S. Food and Drug Administration (FDA) rejected the medication, forcing its eventual withdrawal from the Australian and Russian markets, where it had already been licensed. For the study, researchers at Queen Mary University of London used data obtained from the EMA through a Freedom of Information request. They analyzed data from the Phase 3 CLARITY trial, which compared Mavenclad to placebo. The trial's 1,326 participants completed a quality-of-life questionnaire that focused on disease aspects such as mobility, self-care, usual activities, pain or discomfort, and anxiety. After two years, those on Mavenclad had significantly improved their quality of life compared to the control group, particularly in terms of self-care. Mavenclad also helped mobility, which might be related to its ability to prevent relapses and delay progression, researchers said. While researchers assessed quality of life using two different questionnaires, patients had only completed one in sufficient numbers to allow for a solid analysis. The other quality-of-life tool provided researchers with numerically positive results, but the low number of responses made the result difficult to interpret. This wasn't the first time QMUL researchers have contributed in this way to knowledge of Mavenclad in MS. In 2015, they used a Freedom of Information request to obtain data showing that Mavenclad was not related to increased cancer risk. ā€œCladribine seemed to have such excellent potential as a treatment for MS that we thought it was tragic the development program was shelved, and significant parts of the clinical trial data remained unpublished,ā€ study leader Klaus Schmierer, a neurologist at both QMUL and Barts Health NHS Trust, said in a press release. ā€œIn addition to the drug being highly effective, well tolerated and safe as far as short-term studies can show, we now know it also improves patientsā€™ quality of life. The new results seemed so clear, we felt it was extremely important to publish and share these data." Mavenclad has now been studied in some 2,700 patients with relapsing MS in the Phase 3 trials CLARITY, CLARITY EXTENSION, and ORACLE-MS, as well as the Phase 2 ONWARD trial, and the ongoing long-term study PREMIERE. The treatment differs from most other oral MS therapies in that a short treatment course ā€” a maximum 20 days ā€” triggered effects that were upheld for two years. Studies of Mavencladā€™s mechanisms suggest the drug gets such results by resetting the immune system. In June 2017, the EMA's Committee for Medicinal Products for Human Use urged the European Commission to approve Mavenclad. Merck also plans to seek U.S. approval for its therapy and is now in talks with the FDA about Mavenclad's future.

#ECTRIMS2016 – Data on Merck Treatment for Relapsing MS, Cladribine Tablets, Show Long-Term Benefit

MerckĀ recently presented new efficacy data from itsĀ three Phase 3 clinical trials, showing that a relatively short course of treatment withĀ Cladribine tabletsĀ led to long-term reductions in annualized relapse rate (ARR) in people with relapsing multiple sclerosis (RMS). The data were givenĀ in two oral presentationĀ at the 32nd Congress of the…

#ECTRIMS2016 – Investigational Leustatin Tablets Offer Clinical Benefits to Different MS Patients

Leustatin (cladribine) tablets, an investigational drug, were shownĀ to be effectiveĀ at reducing annual relapse rates, not only in MS patients, but also inĀ patients with a first demyelinating event who later converted to a clinically defined multiple sclerosis diagnosis. The results were shared in a presentation titled ā€œCladribine tablets in the ORACLE-MS…

Merck KGaA’s Investigational MS Therapy Cladribine Gets EMA Marketing Authorization Application Review

Merck KGaA, Darmstadt, GermanyĀ recently announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) of the company’sĀ investigational productĀ Cladribine Tablets as a therapy forĀ relapsing multiple sclerosis (RMS) in Europe. Cladribine is a synthetic antineoplastic agent able to suppress the immune system, causing relatively few…