Glaxo gains priority drug review

Posted on 3 Mar 2008 by The Manufacturer

GlaxoSmithKline has been awarded priority US Food and Drug Administration review of its experimental platelet-boosting drug Promacta.

The fast-track process will mean the health regulators are likely to decide whether or not to approve the new product within six months, rather than the usual 10 months.

Glaxo is also likely to submit an application to market the drug in Europe in 2008.

“The FDA designation of our submission for priority review is very encouraging and brings us closer to offering physicians and their patients [Promacta],” said Paolo Paoletti, head of oncology medicine for GlaxoSmithKline.