FDA's Anti-Infective Drugs Advisory Committee Review of Restanza

Advanced Life Sciences Holdings, Inc. announced today that the FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza(TM) (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP) (11 positive, 3 negative, 1 abstaining). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP (3 positive, 11 negative, 1 abstaining).

"We believe in Restanza's potential and remain committed to its development. We were particularly encouraged by the supportive comments of several members of the committee relative to their positive review of the safety profile of Restanza, the therapeutic need for more effective treatments for CAP and their interest in seeing the company pursue further development," said Dr. Michael Flavin, Chairman and CEO of Advanced Life Sciences. "As we have throughout the review process we will continue to work closely with the FDA as they complete their assessment of the Restanza new drug application (NDA)."

Although it is not binding, the Committee's recommendation will be considered by the FDA as it completes its review of Restanza's NDA in CAP. The FDA has established a Prescription Drugs User Fee Act (PDUFA) date of July 31, 2009 for the Restanza NDA.

Source : www.bio-medicine.org