09.01.2015 16:23:06
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Ligand Pharma Partner Retrophin Gets Orphan Drug Designation For Sparsentan
(RTTNews) - Ligand Pharmaceuticals Inc. (LGND) said its partner Retrophin, Inc. (RTRX) has received orphan drug designation from the U.S. Food and Drug Administration or FDA for Sparsentan for the treatment of focal segmental glomerulosclerosis or FSGS.
Sparsentan is an investigational therapeutic agent which acts as both a selective endothelin receptor antagonist and an angiotensin receptor blocker. Retrophin is conducting the Phase 2 DUET trial of Sparsentan for the treatment of FSGS, a leading cause of end-stage renal disease. There are currently no therapies approved for the treatment of FSGS in the U.S.
Ligand licensed worldwide rights of Sparsentan or RE-021, formerly known as DARA, to Retrophin in 2012, at the time of Retrophin's formation.
The Orphan Drug Designation program is intended to encourage companies to develop therapeutics for diseases that affect fewer than 200,000 individuals in the U.S.
Orphan designation will provide Sparsentan with seven years of marketing exclusivity for FSGS if it is approved by the FDA for this indication.
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