GSK Update On FDA Review Of Promacta® (eltrombopag)

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 04 Oct 2008 - 0:00 PDT

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GlaxoSmithKline announced that the United States Food and Drug Administration (FDA)continues to review the new drug application for Promacta® (eltrombopag) beyond the September 19, 2008 action date. GSK continues to work closely with the FDA towards the approval of Promacta in order to provide physicians and chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients with a novel, once-daily oral option.

"Our discussions with the agency are progressing well and we look forward to this innovative new medicine becoming available for patients with ITP in the USA," said Paul Huckle, Senior Vice President, Global Regulatory Affairs, GlaxoSmithKline.

In December 2007, GSK submitted a new drug application to the FDA for Promacta for the proposed indication of the short-term treatment of previously treated patients with ITP. On May 30, 2008, the Oncology Drugs Advisory Committee (ODAC) to the FDA unanimously voted, 16-0, that PROMACTA demonstrated a favourable risk-benefit profile for the short-term treatment of patients with ITP.

GlaxoSmithKline
http://www.gsk.com