GSK Promacta Won FDA Approval as Thrombocytopenia Therapy in Chronic Hepatitis C Patients

GlaxoSmithKline's (GSK) Promacta has won FDA approval as thrombocytopenia therapy in chronic hepatitis C patients.

Promacta, brand name of eltrombopag in the US, will enable thrombocytopenia patients suffering from chronic hepatitis C to commence and sustain interferon-based therapy.

GlaxoSmithKline oncology president Paolo Paoletti said chronic hepatitis C is a significant public health issue.

"Some chronic hepatitis C patients suffer from low blood platelet counts. Commonly prescribed interferon-based therapies can worsen the problem of low blood platelet counts," Paoletti added.

"Today's FDA approval of PROMACTA gives doctors a tool to address the low platelet challenge. This means more chronic hepatitis C patients may be able to start and stay on interferon-based therapy."

The US regulatory body considered data from Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C related Liver DiseasE (ENABLE) 1 and 2 Phase III studies conducted in patients with platelet counts less than 75,000/μL.

Promacta when combined with interferon-based therapy was proven to establish a constant virologic response or viral cure.

Thrombocytopenia is a condition in which a patient's blood contains a lower-than-normal number of platelets resulting in bleeding inside the body or beneath or from the skin.