FDA grants Nile Fast Track designation for cenderitide post-acute development program

Nile Therapeutics, Inc. (Nasdaq: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Nile's post-acute development program for cenderitide, which has the goal of reducing cardiovascular mortality and cardiovascular re-hospitalization in the post-acute period in patients with acute decompensated heart failure.

As previously announced, Nile plans to develop cenderitide as an outpatient therapy to be delivered to acutely decompensated heart failure (ADHF) patients continuously for up to 90 days after discharge from the hospital.  This is a novel therapeutic indication that is being referred to as "post-acute."

"We are very pleased that the FDA has recognized cenderitide's potential to address an important unmet medical need for heart failure patients," said Joshua Kazam, Nile's Chief Executive Officer. "If our post-acute cenderitide program is successful, then we may be able to reduce the annual number of hospital visits for ADHF, potentially saving the health care system billions of dollars."