Glaxo says oral drug raises blood platelet counts
By Deena Beasley
LOS ANGELES (Reuters) - Patients treated with GlaxoSmithKline PLC’s Promacta rather than a placebo were eight times more likely to have sustained increases in platelet counts, according to pivotal trial results announced by the company on Saturday.
Promacta, also known as eltrombopag, was approved by the U.S. Food and Drug Administration last month for the treatment of patients with chronic immune thrombocytopenic purpura (ITP) who have had an insufficient response to steroids, immune-suppressing drugs or surgery to remove the spleen.
ITP is an autoimmune disease which results in low blood platelet counts. Because platelets contribute to blood clotting, patients with low counts bleed more easily than others, heal more slowly and bruise more often.
Promacta, a pill discovered in a collaboration between Glaxo and Ligand Pharmaceuticals Inc, is seen as a competitor to Amgen Inc’s Nplate, an injectable drug approved by the FDA in August for the same patient group.
Glaxo said the six-month, Phase III trial involving 197 patients with chronic ITP also showed that Promacta reduced bleeding. But the drug raised the risk of liver problems — although there were no serious, drug-induced liver injuries.
The company said hepatobiliary laboratory abnormalities were reported in 13 percent of patients taking Promacta, compared with 7 percent of patients on placebo.
Glaxo also said the trial showed no clinical or laboratory symptoms of bone marrow fibrosis in patients taking Promacta.
The trial results were unveiled in San Francisco at a meeting of the American Society of Hematology.
Amgen and Glaxo are slated to announce at the conference on Monday additional trial results for the platelet drugs.
About 60,000 U.S. adults have chronic ITP, according to the companies.
(Reporting by Deena Beasley, editing by Matthew Lewis)
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