Latest approval for Revolade follows on from clearance in EU earlier this year.
Ligand Pharmaceuticals and partner GlaxoSmithKline (GSK) reported approval by the Japanese regulatory authorities for Revolade® (eltrombopag), in the treatment of chronic idiopathic thrombocytopenic purpora (ITP). Approval in Japan covers use of the TPO receptor agonist in adult chronic ITP splenectomized patients who have not responded to other therapies including corticosteroids and immunoglobulins. Revolade has also been cleared as second-line therapy for non-splenectomized adult patients for whom surgery is contraindicated.
Ligand separately reported the award of $1,955,834 in immediately available funds from the U.S. government under the Patient Protection and Affordable Care Act .The funding will be split between eight drug development programs at Ligand.
Revolade was cleared by the European regulatory agencies in March 2010, and was previously granted accelerated approval by FDA, under the trade name Promacta®, in November 2008. Promacta is separately undergoing clinical development by GSK for a range of disorders. The drug is being investigated in Phase III trials in hepatitis C, and Phase II trials for aplastic anemia, MDS, and for use alongside post stem cell transplantation. Another GSK-partnered TPO receptor product, GSK 2285921, is in Phase II trials against thrombocytopenia.
Ligand and what is now GSK teamed up in 1995 to leverage Ligand’s signal-transduction expertise for the discovery of small molecule drugs that control hematopoiesis. The research phase of the collaboration ended in 2001, and GSK has retained responsibility for the development and registration of products resulting from the collaboration. GSK reported global Promacta sales of £21 million in the first nine months of 2010.
Ligand has a broad, partnered clinical-stage pipeline addressing multiple therapeutic fields in collaboration with Pfizer, Merck, AstraZeneca, Celgene, Bristol-Myers Squibb, Roche, and Exelixis. Ligand’s in-house pipeline is headed by the dopamine agonist, Aplindore, which is in Phase II development for the treatment of restless leg syndrome. A selective androgen receptor modulator is approaching Phase II for the treatment of muscle disorders.