Nile Therapeutics, Inc. a biopharmaceutical company that develops novel therapeutics for heart failure patients, announced that the US Food and Drug Administration (FDA) has granted fast track designation to Nile's post-acute development programme for cenderitide, which has the goal of reducing cardiovascular mortality and cardiovascular re-hospitalization in the post-acute period in patients with Acutely 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” he added further.
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 review the NDA from ten to six months. Fast Track designation is intended to bring valuable treatments more quickly to patients in need.
Nile Therapeutics, Inc. is a biopharmaceutical company that develops innovative products for the treatment of cardiovascular disease and other areas of unmet medical needs and intially focusing its efforts on developing its lead compound, cenderitide, a novel rationally designed chimeric peptide in clinical studies for the treatment of heart failure, and CU-NP, a novel rationally designed natriuretic peptide.