Nivalis Therapeutics, Inc. announced the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation for the Company’s lead investigational drug, N91115, a novel stabilizer of the cystic fibrosis transmembrane conductance regulator (CFTR) protein.
[adsense:336x280:8701650588]
The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Through the Fast Track program, a product may be eligible for priority review at the time of a new drug application (NDA) filing and may also be eligible to submit completed sections of the NDA on a rolling basis before the complete application is submitted.
[adsense:468x15:2204050025]
In late 2015, Nivalis announced the first patient was dosed in a Phase 2 clinical study of N91115 in adult patients with CF who have two copies of the F508del mutation, when added to Orkambi™ (lumacaftor/ivacaftor). The company expects data from this trial in the second half of 2016. Nivalis also recently announced that the FDA had granted N91115 Orphan Drug Designation in cystic fibrosis.
