Cardiovascular Outcomes Data Transparency Vexes FDA, Sponsors
FDA plans a public hearing Aug. 11 on confidentiality of interim results in cardiovascular outcomes safety trials, an issue that apparently has led to regulatory delays for Orexigen’s obesity treatment Contrave and Sanofi’s antidiabetic agent lixisenatide.
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Weight loss drug Contrave delayed by three months while sponsor and agency discuss how to handle data transparency for ongoing cardiovascular outcomes trial.
Contrave could be approved by FDA in 2014, making it the third obesity therapeutic to reach the market in the last two years. An interim analysis of the CV outcomes study LIGHT demonstrates a favorable risk-benefit profile, management said.
Proportion of subjects with freedom from exogenous insulin ‘might support the efficacy’ of the allogeneic islet cellular therapy, US FDA says after concluding that issues in two studies limit interpretability of primary analyses based on severe hypoglycemic events and HbA1c levels. An advisory committee will weigh clinical efficacy, safety and product characterization issues.