FDA accepts NDA for kidney failure medication

LEBANON, N.J. The Food and Drug Administration has accepted the last part of a new drug application for a drug to treat a disease that causes kidney failure.

Orphan Therapeutics and Ikaria Holdings announced Friday that the FDA had accepted the final section of its application for Lucassin (terlipressin), designed to treat hepatorenal syndrome Type 1, a disease that causes kidney failure in patients with late-stage liver cirrhosis in the absence of any other cause, resulting in rapid kidney failure and, in 80% of patients, death within three months.

The FDA has given the drug orphan drug status and fast-track designation. The agency gives orphan status to drugs used to treat rare conditions. Ikaria acquired North American rights to Lucassin from Orphan in September.