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 European Commission’s marketing authorization for highly active relapsing MS in August 2017 for all 28 EU member countries plus Norway, Liechtenstein and Iceland. This follows a recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
U.S. and Canadian authorities have still not approved Mavenclad, which is undergoing clinical investigations in both countries.
NICE’s positive recommendation comes only two months winning European Commission marketing authorization.
“We are delighted NICE and the Appraisal Committee have reached this decision, and consider this an important step in enabling rapid patient access to Mavenclad in England, Wales and Northern Ireland,” Simon Sturge, chief operating officer for Merck’s biopharma business, said in a press reelase. “The positive conclusion NICE has reached is testament to the value, cost-effectiveness and innovation Mavenclad brings to the multiple sclerosis treatment paradigm.”
Mavenclad targets lymphocytes — key cells of the immune system — that are believed to contribute to relapsing MS.
Data from five previous clinical trials — Phase 3 trials CLARITY (NCT00213135), CLARITY EXTENSION (NCT00641537) and ORACLE-MS (NCT00725985); the Phase 2 trial ONWARD study (NCT00436826) and the long-term study PREMIERE (NCT01013350) — established Mavenclad as the first short-course oral therapy achieving a sustained disease control for up to four years with a maximum of 20 days of treatment over two years.
Mavenclad is recommended to patients who show specific features including: rapid progression of severe relapsing-remitting MS – at least two relapses in the previous year and a minimum of one T1 gadolinium-enhancing lesion at baseline (measured by magnetic resonance imaging); or relapsing-remitting MS that failed to respond adequately to disease-modifying therapies (defined as one relapse in the previous year and MRI evidence of disease activity).
“Oral Cladribine Tablets (Mavenclad) brings people with multiple sclerosis sustained clinical efficacy for up to four years with a maximum of 20 days of oral treatment over two years,” said Gavin Giovannoni, a neurology professor at Barts and The London School of Medicine and Dentistry, Queen Mary University of London.
“This expedited recommendation is unprecedented in multiple sclerosis and highlights the significant value Mavenclad offers the NHS [National Health System] and other healthcare systems,” he said. “The ease of use, low monitoring and treatment burden of this short-course oral therapy will free up much-needed resources within the NHS.”