GlaxoSmithKline receives FDA approval for Promacta

Source: Healthcare Exec

Date :03/03/2008 15:57:54

The experimental platelet-boosting drug Promacta been granted priority review by U.S. health regulators, boosting prospects for its early launch, GlaxoSmithKline Plc said on Monday.

A priority review means the U.S. Food and Drug Administration is likely to decide within six months whether to approve the treatment, rather than the usual ten month review period.

Glaxo, Europe's biggest drugmaker, said it also planned to submit a marketing application in 2008 for the drug in Europe, where it will be sold as Revolade.

Collaboration

The once-daily oral treatment is designed for the short-term treatment of patients with chronic idiopathic thrombocytopenic purpura (ITP), 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.

It was discovered as a result of a research collaboration between Glaxo and Ligand Pharmaceuticals Inc., the U.S. biotechnology company.

March 03, 2008