MHRA (UK) extends indication of Mavenclad (cladribine tablets) for relapsing forms of multiple sclerosis – Merck KGaA

Mavenclad (cladribine tablets) from Merck KGaA, is now indicated for the treatment of adult patients with relapsing forms of Multiple Sclerosis (MS) with active disease as defined by clinical or imaging features following approval by the MHRA, meaning more newly diagnosed patients could be eligible for treatment earlier in their disease course.

The approval in Great Britain makes the MHRA the first regulator in Europe to approve cladribine tablets for active relapsing MS. By allowing earlier use of cladribine tablets in the treatment pathway, this approval will expand access for the eligible patient population and will provide a new treatment option for these patients, improving patient outcomes and quality of life. he evidence and data show a favourable benefit to warrant use in this wider population.

Cladribine tablets first received regulatory approval for patients in Great Britain in 2017 for highly active relapsing MS as defined by clinical or imaging feature. In 2023, cladribine was included in the World Health Organisation’s Essential Medicines List.

Following the MHRA’s decision, Merck KGaA will be seeking reimbursement for use in the NHS. If successful, this would make cladribine tablets available to more patients in England, Wales, and Northern Ireland.