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 development for our company, affirming our belief in cladribine tablets as a potential important treatment option for patients living with multiple sclerosis,” Belén Garijo, a Merck board member, said in a press release.
“We now eagerly await the European Commission decision, and the opportunity to make a difference in the MS treatment paradigm,” he said. “Our sincerest thanks to the entire MS community for their unwavering support throughout the cladribine tablets journey.”
Cladribine, whose proposed trade name is Mavenclad, has globally completed its pivotal clinical trial program. The company plans to pursue regulatory approvals worldwide, including in the U.S., where conversations are ongoing with the Food and Drug Administration (FDA).
Merck’s application to market cladribine in the EU was based on results of clinical trials that included about 2,700 patients and that followed some patients more than 10 years. The European Commission is expected to make a final decision on the application within 67 days of receiving the European Medicine Agency recommendation.
Information from three Phase 3 clinical trials, a Phase 2 trial and a long-term follow-up study have shown cladribine tablets to be safe and effective against relapse-remitting MS (RRMS).
The Phase 3 trials are CLARITY (NCT00213135), CLARITY EXTENSION (NCT00641537), and ORACLE-MS (NCT00725985). The Phase 2 trial is ONWARD study (NCT00436826), and the ongoing long-term study PREMIERE (NCT01013350).
Collectively, the trials have yielded information about cladribine dose levels, monitoring requirements, and side effects.
In the CLARITY trial, cladribine reduced the annual relapse rate of RRMS patients by 67 percent. Another key finding was that cladribine significantly reduced the risk of a patient’s disability worsening after six months, compared with a placebo. The risk was 82 percent lower among cladribine patients than placebo patients.
The CLARITY EXTENSION trial demonstrated cladribine’s long-term ability to control the disease. Patients received up to 20 days of treatment over two years. No additional treatments were required in years 3 and 4.
“We strongly believe in the therapeutic value of cladribine tablets and the significant impact this investigational therapy may have on the future of MS care,” said Luciano Rossetti, the head of Merck’s biopharma business research and development arm.
“There are still significant unmet needs for patients with MS, particularly those with high disease activity,” he said. “We look forward to our continued partnership with the EMA (European Medicines Agency), which has been an invaluable scientific advisor in helping us advance the development of cladribine tablets.”