Promacta Approved for Thrombocytopenia
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