On the 7th March 2017, the European Medicines Agency (EMA) granted marketing authorization to LEDAGA® (chlormethine gel, 160μg/g) to treat Mycosis Fungoides-type Cutaneous T-Cell Lymphoma (MF-CTCL).
The approval of Actelion’s LEDAGA® comes after a positive opinion that was given by the EMA’s Committee for Medicinal Products for Human Use (CHMP) last year, in December 2016. The positive opinion, and the subsequent approval, were based on results of the pivotal 201 study (NCT00168064), previously reported by the Lymphoma Hub.
LEDAGA® has already been approved by the U.S. Food and Drug Administration (FDA) in this indications, and is marketed as VALCHLOR®. A European launch of LEDAGA® is expected to take place after January 2018.
- The Pharma Letter. Actelion’s Ledaga approved in EU for the treatment of MF-CTCL. 2017 Mar 7. http://www.thepharmaletter.com/article/actelion-s-ledaga-approved-in-eu-for-the-treatment-of-mf-ctcl. [Accessed 2017 Mar 8].