Published On: Sat, Mar 11th, 2017

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

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Actelion recent news : The (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 .

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.

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.

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.

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 rash that may be itchy or not. It is usually confused for psoriasis or , this delaying correct diagnosis, and in turn the CTCL MF treatment.

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