The FDA has granted orphan drug designation to Nivalis Therapeutics Inc’s N91115 for the treatment of patients suffering from cystic fibrosis, according to a report by Zacks.com.
According to the report, the status makes N91115 eligible for seven years of marketing exclusivity in the US, following an approval for cystic fibrosis. The designation also makes the company eligible for certain other benefits, including tax credits related to clinical trial expenses, exemption from the FDA-user fee and assistance from the FDA in clinical trial design, Zacks.com reported.
Nivalis will seek FDA Fast Track status for N91115, according to the report. Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need, according to the FDA website.
Currently, N91115 is being evaluated in a 12-week phase II study in adults suffering from cystic fibrosis who are homozygous for the F508del-CFTR mutation and are being treated with Vertex Pharma’s Orkambi, Zacks.com reported.