The European Commission grants marketing authorisation to Actelion's Ledaga.
M2 PHARMA-March 9, 2017-The European Commission grants marketing authorisation to Actelion's Ledaga
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The European Commission has granted marketing authorisation to Switzerland-based Actelion for its Ledaga (chlormethine gel) 160 micrograms/g intended to treat mycosis fungoides-type cutaneous T-cell lymphoma, it was reported yesterday.
The product is formulated as a topical, once-daily and colourless gel.
The approval was based on the results of the pivotal 201 study, which included around 260 patients. In the randomised controlled study, around 77% of patients within the efficacy evaluable population who have been treated for around six months with chlormethine gel indicated a clinical response in the composite assessment of index lesion severity score, while 59% of those treated with the compounded control had a clinical response. The 201 is a multicenter, observer-blinded, active-controlled and 12-month trial that included Stage I and IIA MF-type CTCL patients.
Since 2013, the chlormethine gel has been marketed in the US under the brand name Valchlor (mechlorethamine).
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|Date:||Mar 9, 2017|
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