Actelion receives EU approval for new lymphoma therapy Ledaga

Actelion has announced that its new lymphoma therapy Ledaga has been approved by the European Commission.

The regulatory body has granted marketing authorisation for the use of Ledaga in the treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL), a rare and potentially deadly form of the disease.

Data from the pivotal 201 study, which was the largest randomised controlled study ever conducted in early stage MF-CTCL, showed that the drug was able to deliver encouraging response rates in terms of lesion severity.

MF-CTCL cells can metastasise to other body tissues, including the liver, spleen and lungs. The condition is considered difficult to treat due to the unpredictability of its course of development.

The company has agreed to a list of post-approval measures with the European Medicines Agency's Committee for Medical Products for Human Use, with the first European launch of Ledaga expected in January 2018 at the earliest.

By this point, Actelion will be operating as part of the Johnson and Johnson group, following the agreement of a takeover deal earlier this year.

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