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June 13, 2014
07:32 EDTLGNDLigand says Phase 3 PETIT2 study met primary endpoint
Ligand Pharmaceuticals (LGND) announces that its partner, GlaxoSmithKline (GSK), presented the results from the Phase 3 PETIT2 study evaluating the efficacy of eltrombopag vs. placebo in pediatric patients with chronic immune thrombocytopenic purpura. Eltrombopag - marketed as Promacta in the U.S. and as Revolade in Europe and other countries across the world - met its primary endpoint, achieving a statistically significant improvement in platelet counts with almost 40% of patients treated with eltrombopag attaining a consistent platelet response for 6 of 8 weeks compared to placebo. The PETIT2 study results were highlighted today as part of a Press Briefing and Oral Presentation at the European Hematology Association Annual Congress in Milan, Italy. GSK also announced that it is moving forward with planned regulatory submissions for a pediatric indication in cITP later this year. Efficacy results for PETIT2 were consistent across age cohorts. The safety profile was consistent with the established profile for eltrombopag and no new safety concerns were observed. The most common adverse events occurring most frequently in the eltrombopag arm included nasopharyngitis, rhinitis, cough and respiratory tract infection. Grade 3/4 AEs occurred in 12.7% of patients treated with eltrombopag and 10.3% of patients in the placebo group. Serious AEs were reported in 8% of eltrombopag-treated patients vs. 14% in the placebo arm. Additional results from an early phase study of eltrombopag in previously treated pediatric patients with cITP were also presented at the European Hematology Association Annual Congress.
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September 26, 2014
08:31 EDTLGNDLigand, Merck receive approval for NOXAFIL
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