This is the first NDA approval for one of Ligand’s collaborator programs.
The FDA has granted accelerated approval of GlaxoSmithKline’s (GSK) Promacta® (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. GSK expects eltrompopag to be available next week.
As a result of the FDA’s approval Ligand will be entitled to receive a $2 million milestone payment from GSK and will earn tiered royalties in the range of 5–10% on annual net sales of Promacta.
Promacta is an oral thrombopoietin receptor agonist therapy for the treatment of adult patients with chronic ITP that has been shown in preclinical research and clinical trials to stimulate the proliferation and differentiation of cells in the bone marrow to produce platelets, according to the companies.
“Today marks an important milestone for Ligand as this is the first NDA approval stemming from one of our collaborator programs,” said John L. Higgins, president and CEO of Ligand Pharmaceuticals.
