Posted by Michael Wonder on 31 Jul 2018
FDA accepts file for cladribine tablets as potential treatment for relapsing forms of multiple sclerosis
30 July 2018 - Cladribine tablets is approved as Mavenclad in 38 countries.
Merck, a leading science and technology company today announced that a resubmission of the new drug application for cladribine tablets as a potential treatment for patients with relapsing forms of multiple sclerosis has been accepted for filing by the U.S. FDA.
The acceptance includes close to 12,000 patient years of data with over 2,700 patients included in the clinical trial program, and up to 10 years of safety data in some patients. The clinical development program included data from three Phase III trials, CLARITY, CLARITY EXT and ORACLE MS, the Phase II ONWARD study and long-term follow-up data from the eight-year prospective registry, PREMIERE.
