Ligand Pharmaceuticals partner GlaxoSmithKline has submitted regulatory applications in the US and European Union for the use of eltrombopag (Promacta/Revolade) to increase platelet counts in patients with hepatitis C.
A supplemental new drug application was submitted to FDA for Promacta (eltrombopag) as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection to permit the initiation of interferon-based therapy and to optimize interferon-based therapy.
A variation to the marketing authorization application was submitted to EMA for Revolade (eltrombopag) as a treatment for thrombocytopenia in adult patients with chronic hepatitis C infection to enable the initiation of interferon-based therapy and during interferon-based therapy.
Ligand Pharmaceuticals president and chief executive officer John Higgins said, "The recent successful pivotal trials and now submission of the regulatory applications represent significant milestones for the ongoing commercialization of Promacta/Revolade and, importantly, for adult patients with chronic hepatitis C virus infection and thrombocytopenia."
