Merck’s new MS therapy accepted for European regulatory review

Merck has announced that its new cladribine tablets for the treatment of multiple sclerosis (MS) have been accepted for European regulatory review.

The European Medicines Agency has accepted the marketing authorisation application for cladribine tablets, which are intended for the treatment of relapsing-remitting cases of MS.

This submission is based on data from three phase III studies – CLARITY, CLARITY EXTENSION and ORACLE MS – as well as the phase II ONWARD study. In these trials, cladribine tablets showed significantly reduced relapse rates, risk of disability progression and development of new MS lesions compared to placebo.

Additionally, interim long-term follow-up data from the prospective PREMIERE registry has been highlighted, with the information consisting of more than 10,000 patient years of exposure in total.

Luciano Rossetti, head of global research and development for the biopharmaceutical business of Merck, said: "We believe that cladribine tablets, if approved, would have a first-of-its-kind dosing regimen and serve as an important therapeutic option for patients with relapsing-remitting MS."

This comes after the firm licensed HAPPYneuron's cognitive remediation training programme for people living with MS last month.