Additionally, the NDA has also been granted a priority review designation by the FDA, which means the review period for the NDA is reduced, which allows for the completion of the priority review within six months instead of the standard ten months.
Merck said that its NDA is supported by the results from the Clarity study, a two-year, randomised, double-blind, placebo-controlled Phase III trial evaluating Cladribine tablets in people with relapsing-remitting MS.
Primary endpoint of the Clarity study was the relapse rate over 96 weeks, whereas the secondary endpoints included MRI endpoints, proportion of subjects relapse-free and disability progression at 96 weeks.
Fereydoun Firouz, president and CEO of EMD Serono, the US affiliate of Merck, said: “This is a critical milestone on the path to approval for short course therapy with Cladribine tablets, moving us one step closer to meeting an unmet need as an oral, disease-modifying drug available for relapsing MS. We look forward to working with the FDA throughout the regulatory process.”