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Study of Glaxo platelet drug halted due to clots
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Wed May 12, 2010 4:12pm EDT
* FDA says Promacta study in liver patients halted
* Says more patients on drug got clots vs those on placebo
* Cautions drug not approved for those with liver disease
NEW YORK, May 12 (Reuters) - U.S. regulators said on Wednesday a study among liver-disease patients taking GlaxoSmithKline's Promacta treatment for low blood platelets was halted due to blood-clot safety issues.
The medicine is approved in the United States for treatment of chronic immune idiopathic thrombocytopenic purpura (ITP), a condition in which patients have abnormally low blood-platelet counts for no known cause -- putting them at risk of bruises or serious bleeding.
The U.S. Food and Drug Administration said the halted trial, called ELEVATE, involved patients whose low platelets were due to a known cause: liver damage. The agency, in a notice on its website, said the study was halted after a higher incidence of blood clots was seen in patients taking Promacta than those who received placebos.
Six patients, or 4 percent of patients receiving Promacta, and one patient, or 1 percent of those receiving placebos, experienced blood clots in an important blood vessel system that connects to the liver, called the Portal Venous System, the FDA said.
The FDA said it and Glaxo have reminded healthcare professionals that Promacta is not approved for treatment of patients with ITP that have chronic liver disease.
Platelets are one of the three main components of the blood, and are necessary for the normal blood-clotting process.
"Exercise caution when administering Promacta to patients with hepatic (liver) disease," the alert advised doctors, including use of a lower starting dose in patients with moderate to severe liver disease.
Promacta, approved by the FDA in late 2008 and developed in partnership with Ligand Pharmaceuticals Inc < LGND.O, was once touted by Wall Street as a potential big seller. But it has annual sales of less than $50 million.
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FDA: Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease
Audience: Hematology healthcare professionals
[Posted 05/12/2010] GlaxoSmithKline and FDA notified healthcare professionals of a new safety finding in patients with thrombocytopenia due to chronic liver disease treated with eltrombopag, a thrombopoietin receptor agonist approved for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura. The ELEVATE study, a randomized, double-blind, placebo-controlled, multinational study was terminated following the identification of an imbalance of thrombosis of the portal venous system in the patients treated with eltrombopag versus matching placebo. Six patients (4%) in the eltrombopag group and one (1%) in the placebo group experienced a thrombotic event of the portal venous system. Five of the six patients treated with eltrombopag experienced the portal venous thrombosis at platelet counts above 200,000/µL. GSK has communicated this safety finding to clinical trial investigators and regulatory agencies. GSK is working with regulatory agencies to include this safety information in the label.
Action required by Health Care Professionals:
* Health Care Professionals are reminded that Promacta is indicated for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and is not indicated for the treatment of thrombocytopenia in patients with chronic liver disease.
* Treatment with Promacta should be aimed at increasing the platelet count to a level that reduces the risk of bleeding; Promacta should not be used in an attempt to normalize the platelet count.
* Use caution when administering Promacta to patients with known risk factors for thromboembolism.
* Exercise caution when administering Promacta to patients with hepatic disease. Use a lower starting dose (25mg once daily) of Promacta in patients with moderate to severe hepatic disease and monitor closely.
[05/04/2010 - Dear Healthcare Professional Letter - GSK]
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