Revolade, an oral platelet generator is used to treat thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids,immunoglobulins or splenectomy.
Revolade received orphan drug status in European Union (EU).
Eltrombopag, which is available in the US market under the trade name Promacta, is authorized for use in all 27 member states of the EU.
Further, Votrient is indicated for the treatment of kidney cancer – advanced renal cell carcinoma (RCC).
Votrient is used in 27 member states of the EU, Switzerland, Australia, New Zealand, Canada, Turkey, Korea, Argentina and Russia.
GSK managing director South Asia vice president, India Hasit Joshipura said Votrient approval in India is based on the results from a pivotal Phase III study of patients with advanced kidney cancer who had either received no prior drug treatment, or had failed a cytokine-based treatment.
"Votrient has been proven to significantly delay the progression of advanced renal cell carcinoma while maintaining patients’ quality of life, when compared with placebo," Joshipura said.