Ligand's Partner GSK Gets FDA Approval Of SNDA For Promacta/Revolade

(RTTNews) - Ligand Pharmaceuticals Inc. (LGND) Wednesday said its partner GlaxoSmithKline plc (GSK) has received approval from the US Food and Drug Administration or FDA for a supplemental New Drug Application or sNDA for the once-daily use of Promacta/Revolade in patients with severe aplastic anemia, who have had an insufficient response to immunosuppressive therapy.

Earlier in January 2014, Promacta was granted Breakthrough Therapy designation status from the FDA and Priority Review in April 2014. The new approval was based on results from an investigator-sponsored Phase II study, which showed a hematologic response in severe aplastic anemia patients treated with eltrombopag who had an insufficient response to immunosuppressive therapy.