Orphan Therapeutics, LLC and Ikaria Holdings, Inc announced that the US Food and Drug Administration (FDA) has accepted the final section of the New Drug Application (NDA) filing seeking marketing approval for Lucassin (terlipressin for injection) for the treatment of hepatorenal syndrome (HRS) Type-1.
The filing was completed on May 4, 2009, and Lucassin has been granted Priority Review as well as Orphan Drug status and Fast Track designation.
HRS Type-1 is the development of kidney failure in patients with late-stage liver cirrhosis in the absence of any other cause. It is characterized by rapid onset of renal failure with a high mortality rate that exceeds 80 per cent within three months.
In September 2008, Ikaria acquired the North American rights to Lucassin, including responsibility for manufacturing, distribution, marketing, sales, customer service and post-market development. Those rights will be transferred to Ikaria following marketing approval. Lucassin is a synthetic vasopressin analogue that acts via the vasopressin V1 receptor as a systemic vasoconstrictor, mainly in the splanchnic (abdominal) circulation, which appears to increase effective arterial volume and improves renal blood flow, thereby improving renal function in patients with HRS. Terlipressin was recently approved in France, Ireland, Spain and South Korea for the treatment of patients with HRS Type-1. Terlipressin is not approved by the FDA for use in the US.
Orphan Therapeutics, LLC, is a privately held drug development company dedicated to developing treatments for rare and serious diseases.
Ikaria Holdings is a biotherapeutics company whose acute care products and therapies address the significant unmet needs of critically ill patients.