Mumbai, Jul 22: GlaxoSmithKline Pharmaceuticals Ltd, the Indian unit of GlaxoSmithKline PLC today announced the launch of two drugs in India - Revolade and Votrient.
“Both the drugs, targeted towards specific patient categories, will be imported from UK and marketed by the oncology division of the company,” GlaxoSmithKline Pharmaceuticals India's Managing Director, Hasit Joshipura, told reporters here.
Revolade is approved for oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP).
“Revolade is the first and only oral platelet generator. It is an innovative step forward in helping patients and their physicians meet the challenges of managing chronic ITP. Clinical trials have shown that eltrombopag is able to stimulate the production of platelets and reduce the risk of bleeding in this difficult to treat disease,” Joshipura said.
The Votrient is most common type of kidney cancer. As per estimates, in India, there were 8900 new cases and 5,733 deaths due to kidney cancer in 2008. The worldwide and European incidence of renal cell carcinoma (RCC) is rising by two per cent annually.
“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.
The market for oncology in India is estimated at Rs 1,200 crore and it is growing at 16-18 per cent CAGR, he said. During the year 2011, the company submitted 7 NDAs (New Drug Applications) for various products including vaccines and 2 IND (Investigational New Drug) applications.
The company has received approval for 6 NDAs and 1 IND from Central Drugs Standard Control Organisation (CDSCO), which paves the way for speedy introduction of new drugs. PTI
