Lucassin will be used to treat patients with type 1 hepatorenal syndrome (HRS), a life-threatening condition characterized by rapid kidney failure in patients with end-stage liver cirrhosis, for which there is currently no drug treatment available. Patients with type 1 HRS have an average survival rate of two to four weeks.
The rolling submission process enables companies that have been granted fast track designation by the FDA to submit sections of the new drug application to the agency as they become available.
Orphan Therapeutics also reported that it has agreed to acquire full commercialization rights for Lucassin in North America from PDL BioPharma, its previous marketing partner. By mutual agreement Orphan Therapeutics has assumed marketing rights, and the partnership between the two companies has formally been terminated.