Novartis has received USFDA approval for eltrombopag drug (Promacta for oral suspension, Novartis) for the treatment of thrombocytopenia in paediatric patients.
The approval was based on two randomised, double-blinded, placebo-controlled trials enrolling paediatric patients with chronic ITP. The PETIT trial (Paediatric patients with thrombocytopenia from ITP) was a phase II trial with the primary efficacy endpoint of the proportion of subjects achieving platelet counts greater than or equal to 50 x109/L at least once between days eight and 43 of the randomised period of the study.
Company Profile : Novartis India Ltd
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