Cladribine tablets demonstrated sustained clinical efficacy for up to 4 years treating multiple sclerosis.
The European Commission granted marketing authorization for cladribine tablets (Mavenclad) for the treatment of highly active relapsing multiple sclerosis (RMS).
Cladribine is a short-course oral therapy designed to selectively and periodically target lymphocytes believed to be an integral part of the pathological process of RMS, according to a press release.
The marketing authorization of cladribine is based on more than 10,000 patient years of data with more than 2700 patients included in the clinical development program, and up to 10 years of observation for some patients.
The program included data from the phase 3 trials CLARITY, CLARITY EXTENSION, and ORACLE MS and from the phase 2 ONWARD study. Long-term follow-up data from the 8-year prospective registry PREMIERE were also included.
“This is an exciting moment and one that will change the way we treat MS,” Gavin Giovannoni, professor of neurology at Barts and The London School of Medicine and Dentistry, said in the release. “Mavenclad is a selective immune reconstitution therapy which simplifies treatment administration, by giving patients just two short annual courses of tablets in four years. Patients can benefit from the treatment over a longer period of time without having to continually take medication and without the need for frequent monitoring.”
The marketing authorization follows a positive opinion from the Committee for Medicinal Products for Human Use. It includes the 28 countries of the EU, with first launches in the UK and Germany expected as early as September 2017.
“Multiple sclerosis is one of the world’s most common neurological disorders,” Belén Garijo, CEO Healthcare and Member of the Executive Board of Merck, said in the release. “With the approval of Mavenclad in the European Union, we are pleased to offer patients and clinicians an innovative agent with a simplified dosing schedule as a new approach to managing active relapsing MS. This is a pivotal change in the treatment of MS, which further demonstrates our unwavering commitment to advancing patient care.”
Post hoc analyses of the 2-year CLARITY trial demonstrated that cladribine reduced the annualized relapse rate by 67% in patients with high disease activity, and the risk of 6-month confirmed EDSS progression by 82% compared with placebo
In the phase 3 CLARITY EXTENSION study, treatment with cladribine was not required in years 3 or 4. The most clinical relevant adverse events were lymphopenia and herpes zoster.
“Multiple sclerosis affects more than 700,000 people across Europe and has no cure to date,” Anne Winslow, president of the European Multiple Sclerosis Platform, said in the release. “New treatment options will significantly help improve the quality of life of people living with active relapsing MS."