FDA backs new indication for GlaxoSmithKline's Promacta

The US Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s (LSE: GSK) Promacta (eltrombopag) for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy, the company revealed yesterday.

Promacta is the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based therapy due to their low blood platelet counts. Promacta in combination with interferon-based therapy has been shown to improve a patient's chance of achieving a sustained virologic response (SVR) or viral cure.

Last year, the FDA has granted full approval for Promacta (also sold as Revolade), an oral tablet that can raise platelet counts in patients with the rare blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy (The Pharma Letter February 28, 2011). Approval for the new indication was filed in the USA and Europe earlier this year (TPL March 31). The drug was developed in collaboration with the USA’s Ligand Pharmaceuticals (Nasdaq: LGND).