GlaxoSmithKline plc announced that the U.S. Food and Drug Administration (FDA) has approved Promacta 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. 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.
There are limitations to the use of Promacta in patients suffering from chronic hepatitis C-associated thrombocytopenia. These include:
· Promacta should not be used in an attempt to normalize platelet counts;
· Promacta should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon therapy or limits the ability to maintain optimal interferon-based therapy; and
· Safety and efficacy have not been established in combination with direct-acting antiviral agents approved for treatment of chronic hepatitis C genotype 1 infection.
“Chronic hepatitis C is a significant public health issue,” said Paolo Paoletti, M.D., President, GlaxoSmithKline Oncology. “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. 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. That gives these patients a better chance to achieve a viral cure.”
The approval for Promacta is based on results from ENABLE 1 and 2 (Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C related Liver DiseasE), two Phase 3 randomized, double-blind, placebo-controlled, multicenter studies, which collectively enrolled 1,521 patients with platelet counts <75,000/µL. ENABLE 1 utilized peginterferon alfa-2a (PEGASYS) plus ribavirin for antiviral treatment and ENABLE 2 utilized peginterferon alfa-2b (Pegintron) plus ribavirin.
Date: November 19, 2012
Source: GlaxoSmithKline plc