cladribine tablets

People with multiple sclerosis (MS) who are treated with Mavenclad (cladribine) are less likely to experience a disease relapse than those who are treated with Gilenya (fingolimod), Tecfidera (dimethyl fumarate), or Aubagio (teriflunomide), according to an analysis of real-world data. The findings were presented at the Americas Committee…

As usual, I’ve gone for what I hope to be an intriguing headline, because you’ve got to grab a reader by any means necessary. If you’ve read this far, I’m winning! This saga goes back well over a year, when my neurologist suggested I participate in a clinical trial for…

The Canadian MS Working Group (CMSWG) — made up of neurologists with the Canadian Network of MS Clinics — has updated its recommendations concerning diagnosis and the use of disease-modifying therapies (DMTs) for multiple sclerosis (MS), according to a press release from the MS Society of Canada.

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…

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 — developed by Merck KGaA (known as EMD in North America) — 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 — patients took tablets for a maximum of 20 days over two years — this latest study showed that continuing treatment into the third or fourth year offered no additional benefits. This finding supports Merck’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 patients’ quality of life. As such, the company plans to file regulatory approval for Mavenclad in the United States and elsewhere.

Merck’s cladribine tablets are now just one step away from obtaining European Union approval as a relapsing multiple sclerosis treatment. The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended that the European Commission approve the tablets. “The positive opinion from the CHMP [the committee] is an extraordinary…

Cladribine tablets reduce the risk of disability progression and relapse in patients with relapsing multiple sclerosis (MS), the CLARITY clinical trial indicates. The treatment was also well-tolerated and had a good safety profile, according to a presentation at the Annual Meeting of the American Academy of Neurology (AAN) in Boston,…

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