PharmaIN Corporation and LAT Pharma LLC announced the FDA has granted their request for orphan-drug designation for terlipressin
for the treatment of ascites due to all etiologies except for cancer.
Other omissions relevant to intensive care and cardiac anaesthetic practice include vasopressin, terlipressin
, sildenafil and bosentan.
plus albumin infusion: an effective and safe therapy of hepatorenal syndrome.
has announced that its partner, Orphan Therapeutics LLC, has completed enrollment in the pivotal Phase 3 clinical research study of terlipressin
for the treatment of type 1 hepatorenal syndrome (HRS), a life-threatening complication of liver cirrhosis characterized by rapidly progressive kidney failure.
Clinical review: vasopressin and terlipressin
in septic shock patients.
Similar effects with fewer complications have been obtained using intravenous albumin with terlipressin
, which causes vessel contraction more safely (Gines et al.
Pipeline candidates fall under major therapeutic classes such as stem cell therapy, terlipressin
or vasopressin receptor agonist, anti-viral agent, immunomodulator, ammonia detoxicator and carbon adsorbent.
The Ikaria transaction also builds potential diversity in Mallinckrodt's nephrology rare disease pipeline with terlipressin
(for injection), a portfolio asset being investigated for the treatment of Hepato-Renal Syndrome Type 1 (HRS 1) -- a rare life-threatening condition with no currently approved therapy in the U.
also is approved in France, Ireland, Spain and South Korea for the treatment of patients with HRS Type 1.
Ikaria also acquired the North American rights to terlipressin
, which currently is under review by the FDA for the treatment of hepatorenal syndrome Type 1.
in the US, its territories, and Canada.
for the treatment of Type 1 hepato-renal syndrome (HRS), providing seven years marketing exclusivity upon the completion of clinical studies and FDA approval of the drug for this indication.