ALLSCHWIL/BASEL, SWITZERLAND - 16 December 2016 - Actelion Ltd (SIX: ATLN) announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), issued a positive opinion for the use of chlormethine gel 160 micrograms/g (Ledaga�) for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) in adult patients and recommended that the European Commission approves the product. The CHMP opinion is based on the results of the pivotal 201 study, the largest randomized controlled study ever conducted in MF-CTCL involving 260 patients. In this study 77% of patients who were treated for at least 6 months with...
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Actelion receives positive CHMP opinion for chlormethine gel (Ledaga) for the treatment of MF-CTCL
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