SAN MATEO, Calif., March 31, 2011 /PRNewswire/ — 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.”
Fast Track is a designation that the FDA reserves for products
that demonstrate the potential to address unmet medical needs for
serious or life-threatening conditions. The Fast Track process is
designed to facilitate the development and expedite the review of
these products. The FDA has a number of pathways intended to meet
these goals, including more frequent interactions with the FDA
throughout the development process. In addition, sponsors of drugs
that receive Fast Track designation can file a new drug application
(NDA) on a rolling basis as data become available and have the
possibility to be considered for Priority Review, which could
reduce the time it takes the FDA to
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