Actelion’s Ledaga Chlormethine Gel for CTCL MF treatment gets EC approval

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Actelion recent news : The European Commission (EC) has approved Actelion Pharmaceuticals’ marketing authorization for its Ledaga Chlormethine Gel 160 micrograms/g for cutaneous T-cell lymphoma mycosis fungoides-type treatment, shortened as CTCL MF treatment.

Ledaga Chlormethine Gel Details

Approval of the topical, daily once and colorless gel by the EC comes in the wake of the positive results demonstrated in a crucial trial named Study 201 featuring 260 patients.

Ledaga (chlormethine) is an alkylating drug which has been formulated in a gel form.

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Actelion demonstrated that 77% of patients among the efficacy evaluable (EE) population whose CTCL MF treatment was through Ledaga chlormethine gel had shown a clinical response in the composite assessment of index lesion severity (CAILS) score. On the other hand, there was clinical response shown by 59% of the patient population treated with the compounded control.

Actelion Pharmaceuticals

Actelion recent news . Photo courtesy of Actelion Pharmaceuticals Ltd.

The efficacy and safety Study 201 was an observer-blinded, active controlled and held across 13 American centres for 12 months in stage 1 and stage 2A cutaneous T cell lymphoma patients having the mycosis fungoides-type form.

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As per the Actelion recent news, the pharma had the 260 CTCL MF patients randomized in a 1:1 ratio to receive topical CTCL MF treatment with either its Ledaga Chlormethine Gel or with Aquaphor ointment with chlormethine HCl 0.02% compound, both applied daily once for up to a period of one year.

CTCL MF Fast Facts | Mycosis Fungoides Type Cutaneous T cell lymphoma

MF-CTCL or CTCL MF, a common form of cutaneous T-cell lymphoma, is a rare type of immune system cancer which can be life threatening and forms on the skin.

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This type of cutaneous T-cell lymphoma commonly affects patients of over 50 years, particularly in men.

MF-CTCL begins giving dry skin and presents a red rash that may be itchy or not. It is usually confused for psoriasis or eczema, this delaying correct diagnosis, and in turn the CTCL MF treatment.

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