Reuters logo
US FDA panel backs Astellas drug for leaky bladder
April 5, 2012 / 7:42 PM / 6 years ago

US FDA panel backs Astellas drug for leaky bladder

SILVER SPRING, Md., April 5 (Reuters) - U.S. drugs advisers backed Astellas Pharma Inc’s bladder drug on Thursday, boosting the company’s hopes of gaining a greater foothold in the treatment of overactive bladder.

A panel of outside advisers to the U.S. Food and Drug Administration voted 7 to 4, with one abstention, that the benefits of the once-daily tablet, called mirabegron, outweighed its possible risks to the heart and liver.

The FDA usually follows panel recommendations, although it is not required to, and will make a final decision on mirabegron by June 29.

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below