What is Ledaga - Clormetina and what is it used for?
Ledaga is a medicine used to treat adults with skin cancer called cutaneous T cell mycosis fungoides. The medicine contains the active substance clormetina.
Because the number of patients with this skin cancer is low, the disease is considered "rare" and Ledaga was designated an "orphan medicine" (a medicine used in rare diseases) on 22 May 2012.
Ledaga is a "hybrid" medicine. This means that it is similar to a "reference medicine" (in this case Caryolysine) which contains the same active ingredient and is used for the same purpose. The difference between Ledaga and Caryolysine is that Ledaga is available in gel and Caryolysine was available as a liquid to be diluted before application on the skin.
How is Ledaga - Clormetina used?
Ledaga can only be obtained with a prescription. Treatment with Ledaga should be started by a physician with adequate experience.
Ledaga, which is available as a gel, is applied once a day in a thin layer on the affected areas of the skin. It must be applied with caution to avoid making it come into contact with areas not affected by the disease. Treatment should be discontinued if patients develop blisters or open sores. For more information, see the package leaflet.
How does Ledaga - Clormetina work?
The active substance in Ledaga, clormetin, belongs to a group of anticancer medicines called "alkylating agents". The alkylating agents work by binding to the DNA of the cells as they divide. The result is that cancer cells cannot divide and eventually die.
What benefit has Ledaga - Clormetina shown during the studies?
The company provided data from the published literature, which shows that clormetin, the active ingredient of Ledaga, is effective in the treatment of cutaneous T-cell mycosis fungoid fungi.
Furthermore, a study of 260 patients found that Ledaga was at least as effective as an ointment containing the same amount of clormetin. The effectiveness of the ointment was considered comparable to that of the reference medicine, Caryolysine. Efficacy was measured as a complete or partial improvement in the "CAILS" score, which takes into account different characteristics of the cancer, such as the size and appearance of the skin lesion. Ledaga was effective in 58% of patients (76 of 130 patients) after at least six months of treatment compared to 48% of patients (62 of 130) who used ointment.
What are the risks associated with Ledaga - Clormetina?
The most common side effects of Ledaga (which may affect more than 1 in 10 people) are dermatitis (inflammation of the skin with redness, rash, pain and burning sensation), skin infection and itching. For the full list of side effects and limitations, see the package leaflet.
Why has Ledaga - Clormetina been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ledaga had shown a comparable safety and efficacy profile to Caryolysine and satisfactory quality. Therefore, the CHMP considered that, as in the case of Caryolysine, the benefits outweigh the identified risks and recommended that they be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Ledaga - Clormetina?
The company that markets Ledaga will supply material to avoid accidental contact with the medicine, especially in the eyes and inside the nose and mouth. This material will consist of a sealable child-proof plastic bag to safely store the medicine in the refrigerator and in a patient alert card with instructions on how to properly apply the medicine.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ledaga have also been included in the summary of product characteristics and the package leaflet.
More information on Ledaga - Clormetina
For the full EPARP of Ledaga consult the website of the Agency: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Ledaga therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The summary of the opinion of the Committee for Orphan Medicinal Products related to Ledaga is available on the Agency's website: ema.europa.eu/Find medicine / Human medicines / Rare disease designation.
