GlaxoSmithKline receives approval in Japan from the Ministry of Health

GlaxoSmithKline announced that it has received approval in Japan from the Ministry of Health, Labour and Welfare for Revolade (eltrombopag) for the treatment of the blood disorder, chronic idiopathic thrombocytopenic purpura (ITP), and for Xyzal (levocetirizine dihydrochloride), the first new anti-histamine to be made available in Japan for eight years. Revolade is the world’s first oral treatment that stimulates the production of blood platelets, which are essential to normal clotting. ITP patients experience bruising and bleeding and, in some cases, serious haemorrhages, which can be fatal. ITP may also affect a patient’s quality of life, as it is often associated with fatigue and depression and a fear of bleeding may limit everyday activities.

The anti-allergic drug, Xyzal, has been approved for the treatment of allergic rhinitis, urticaria, eczema and dermatitis, prurigo, and cutaneous pruritus in patients over the age of seven years.

Philippe Fauchet, President of GSK Japan, commented, “These approvals are very important to GSK as they demonstrate the progress we are making in gaining approvals in Japan for products that we believe can offer real value to patients.  I believe this illustrates GSK’s commitment to actively developing treatments for diseases that affect broad groups of patients, such as allergic rhinitis, but also for rare and difficult to treat diseases, where only a small number of patients exist, such as ITP.