Ledaga Overview

This is a summary of the European public assessment report (EPAR) for Ledaga. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ledaga.

For practical information about using Ledaga, patients should read the package leaflet or contact their doctor or pharmacist.

The active substance in Ledaga, chlormethine, belongs to the group of cancer medicines called ‘alkylating agents’. Alkylating agents work by attaching to the DNA of cells while the cells are dividing. As a result, cancer cells cannot divide and they eventually die.

The company provided data from the published literature showing that chlormethine, the active substance in Ledaga, is effective in treating mycosis fungoides-type cutaneous T-cell lymphoma.

In addition, a study involving 260 patients found that Ledaga was at least as effective as an ointment containing the same amount of chlormethine. The ointment’s effectiveness was considered comparable to that of the reference medicine, Caryolysine. Effectiveness was measured as complete or partial improvement in the ‘CAILS’ score, which takes into account different features of the cancer, such as the size and appearance of the skin damage. Ledaga was effective in 58% of patients (76 patients out of 130) after at least 6 months of treatment compared with 48% of patients (62 out of 130) using the ointment.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Ledaga has shown comparable safety and effectiveness to Caryolysine and has shown satisfactory quality. Therefore, the CHMP’s view was that, as for Caryolysine, the benefits outweigh the identified risks. The Committee recommended that Ledaga be approved for use in the EU.


What are the risks associated with Ledaga?

The most common side effects with Ledaga (which may affect more than 1 in 10 people) are dermatitis (skin inflammation with reddening, rash, pain and burning sensation), skin infection and itching.

Owner of copyright and other intellectual property rights to European Medicines Agency

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