Biopharma Business

Actelion gets EU Approval to Launch a Treatment for a Rare Skin Cancer

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Actelion gets EU Approval to Launch a Treatment for a Rare Skin Cancer

March 07
12:19 2017

Actelion has received approval from the European Commission for Ledaga, a treatment to prevent the progression of a rare form of skin cancer.

After being acquired by Johnson & Johnson in a huge €28Bn deal, Actelion has faced some issues regarding one of its leading drugs, Uptravi, being linked to patient deaths and a failed Phase III trial to expand the indications of another of its top products, Opsumit. But the company is now bringing good news; theEuropean Commission has approved Ledaga, a treatment for a rare form of skin cancer called mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL).

MF-CTCL is a life-threatening immune system cancer that appears in the skin, typically in people over 50 years old. Its progression is usually slow, but when it reaches an advanced stage it can metastasize to other organs. Ledaga is a gel intended to prevent the progression of the disease to increase patient survival.

The active compound in Ledaga is chlormethine, which can be considered the parent of modern day chemotherapy. The drug was initially developed as an analogue of mustard gas in warfare research. The first studies of chlormethine as a treatment for lymphoma and leukemia date back to 1942, but results were kept secret for years because of secrecy policies during WW2.

The approval of Ledaga is based on a clinical study in MF-CTCL comparing Actelion’s Ledaga with Aquaphor, a skin ointment developed in the 20s and still widely used to treat skin conditions. The ointment is manufactured by the German firm Beiersdorf, owner of the popular Nivea brand.

Actelion’s new approval in an indication outside its specialty, pulmonary artery hypertension (PAH), will likely not bring as much revenues as its top PAH drugs, Opsumit (macitentan) and Uptravi (selexipag). However, a diverse portfolio is key for a big company to compensate for any unexpected issues arising from the pipeline or marketed products. For example, Actelion is also developing what could be the first-ever combination therapy for multiple sclerosis (MS), and its pipeline includes indications ranging from oncology to infectious disease.


Written by Clara Rodríguez Fernández

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