Galen, a global pharmaceutical company, has announced that the European Commission has designated liposomal daunorubicin as orphan medicinal product for the treatment of acute myeloid leukaemia (AML). The appointment follows the positive opinion from the Committee for Orphan Medicinal Products (COMP) within of the European Medicines Agency (EMA).
Liposomal daunorubicin is an anthracycline chemotherapeutic agent that has been approved in several countries in Europe, the US and Brazil for the treatment of advanced Kaposi sarcoma related to HIV, such as medical product DaunoXome. Work attacking cancer cells and interfering with the production of DNA, thus stopping the multiplication of cancer cells. The product has a different delivery system in comparison with conventional anthracycline; has a coating type and liposomal particle size, allowing you to effectively target malignant tumours.
Acute myeloid leukaemia is estimated to affect more than 1.2 in 10,000 people in the European Union. It is a chronic debilitating disease that poses a threat to life due to bone marrow failure. If left untreated, the disease progresses quickly and is often fatal.
Galen is dedicated to supporting the development and supply of innovative medicines in an effort to improve health worldwide.
Mark Scrutton , Galen CEO commented: "We are delighted to liposomal daunorubicin designation as orphan medicinal product for the treatment of acute myeloid leukaemia, a disease that threatens life. recently we have taken the first steps in the field of oncology, and liposomal daunorubicin orphan designation provides another opportunity for the development of this product in the treatment of patients with AML. "