Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Orphan Therapeutics plans to initiate a rolling submission in the second quarter of 2007 for a new drug application with the FDA to commercialize Lucassin, its drug for treating an aggressive form of liver disease.
Subscribe to our email newsletter
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.