Glaxo Submits Promacta to FDA
By KEVIN KINGSBURY and ELENA BERTON
December 20, 2007 7:42 a.m.
GlaxoSmithKline PLC filed for U.S. Food and Drug Administration approval of its
blood-platelet booster drug Promacta, which a study has shown sustains increased platelet count during long-term treatment.
The company had been expected to make its filing by year-end.
Known generically as Eltrombopag, the drug
works by stimulating production of platelets in the bone marrow of patients suffering from chronic idiopathic thrombocytopenia purpura, or ITP. The ailment causes an increased risk of bruising and bleeding.
Preliminary results from an continuing late-stage trial of Promacta were presented last week at the American Society of Hematology meeting in Atlanta. The treatment also showed it was well tolerated in the 94 patients taking part in the study, GlaxoSmithKline said.
Currently undergoing late-stage trials, the treatment is expected to be launched as Revolade in Europe, where marketing approval is expected to be sought next year. Analysts have estimated the product, which has also shown promising efficacy on hepatitis C patients with ITP during mid-stage clinical trials, could have a market opportunity of around $3 billion after it is launched.
Source: Wall Street Journal
Glaxo Submits Promacta to FDA - WSJ.com