FDA approval for GSK's Avodart

UK drug major GlaxoSmithKline has received approval from the US Food and Drug Administration for Avodart (dutasteride), in combination with tamsulosin, for the treatment of symptomatic enlarged prostate.

The approval is based on the results of the CombAT study, which showed that a combination of the alpha-blocker tamsulosin, originated by Boehringer Ingleheim as Flomax and approved for treatment of the symptoms of enlarged postate, with Avodart, cleared to treat the disease itself, was more effective than either drug as monotherapy. The results of the CombAT study were reported at the 2007 meeting in France of the International Urology Society and published in the Journal of Urology.

"The combination of Avodart and tamsulosin at diagnosis allows doctors to simultaneously treat the patient's prostate on two fronts: by reducing prostate size and rapidly improving symptoms," said Steven Kaplan of Cornell University in New York.