January 22, 2015 / 7:17 PM / 3 years ago

FDA panel backs Astellas drug for invasive fungal infections

Jan 22 (Reuters) - A panel of experts on Thursday voted to recommend that U.S. health regulators approve Astellas Pharma Inc’s isavuconazonium for the treatment of rare, often fatal invasive fungal infections that can hit patients with blood cancers.

The panel voted 11-0 that the Japanese drugmaker had demonstrated sufficient safety and efficacy to support approval of isavuconazonium to treat invasive aspergillosis.

It voted 8-2 with one abstention to recommend the drug to treat invasive mucormycosis.

The Food and Drug Administration, which typically follows the recommendations of its advisory panels but is not obligated to do so, is expected to make its approval decision by March 8. (Reporting by Bill Berkrot in New York; Editing by Bernard Orr)

Our Standards:The Thomson Reuters Trust Principles.
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