Actelion receives EU approval for MF-CTCL gel Ledaga

Actelion Pharmaceuticals has announced that the European Commission has granted its approval to Ledaga, a gel made from chlormethine designed to treat patients with mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL).

MF-CTCL is a chronic immune disease that develops slowly but can prove life-threatening if its effects spread to the vital organs, which occurs in approximately one-third of cases.

However, trials involving Ledaga showed the gel to be effective in achieving a clinical response in more than three-quarters (77 percent) of patients with the disease. For the purpose of the trials, a clinical response was designed as an improvement of at least 50 percent in a patient's Composite Assessment of Index Lesion Severity score.

Now that Actelion has received authorisation for marketing Ledaga in the EU, the earliest date that it will be available to purchase will be January next year. The pharmaceutical firm now needs to submit a list of post-approval measures to the Committee for Medical Products for Human Use.

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