Merck KGaA received word July 25 that its application for the multiple sclerosis treatment Cladribine had received priority review status by FDA, decreasing the evaluation period from 10 months to six months, and closing the gap between Merck and the competition.
“This is a critical milestone on the path to potential 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,” stated Fereydoun Firouz, president and CEO of Merck’s US affiliate, EMD Serono, in a release.
FDA originally rejected Merck’s application for any kind of approval in November 2009, prior to the release of CLARITY trial data. It’s possible that FDA reconsidered the application after reviewing the positive results from the two-year global study of 1,326 patients suffering from relapsing-remitting MS.
According to Merck KGaA, patients taking the short-course tablet treatment experienced “rapid and sustained improvements in clinical and magnetic resonance imaging outcomes, which were accompanied by rapid and sustained effects on blood-cell subtypes implicated in the pathogenesis of multiple sclerosis.”
Gavin Giovannoni, principal investigator of the study, told ThePharmaLetter, “The introduction of an oral therapy, particularly one that has no short-term side effects and is as easy to use as oral Cladribine, will have a major impact on the treatment of MS. However, the use of this drug as a first-line therapy will have to be weighed up against the potential long-term risks which have yet to be defined.”
Side effects included headaches, upper respiratory tract infections and nausea—similar to adverse reactions experienced by patients taking the placebo.
Merck is neck-and-neck with Novartis, which received priority review for its own MS tablet-based treatment, Gilenia, in February. There are currently no non-injectable MS treatments on the market, so an early approval is going to be a big win for patients and a financial windfall for whichever company is first to market.