Orphan Therapeutics today announced that it has begun submission of the rolling Lucassin(R) (terlipressin) New Drug Application (NDA) for the treatment of hepatorenal syndrome (HRS) type 1 in patients with late-stage liver cirrhosis. LUCASSIN(R) had previously been granted orphan status and fast track designation for this indication by the U.S. Food and Drug Administration (FDA). Currently no drug is approved in the U.S. to treat HRS type 1, a rare and life-threatening condition in late-stage liver disease.
The whole story can be read here.
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