Intercept quiet on NASH safety data disclosure concerns

May 23 2014

• By Mandy Jackson

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Intercept Pharmaceuticals is not commenting on reports that the company did not appropriately disclose safety information about its lead drug candidate obeticholic acid (OCA), but Intercept released a set of e-mail messages on 22 May that show the company knew about OCA's impacts on cholesterol in the investigator-sponsored FLINT trial as early as 6 January.

Intercept Pharmaceuticals is not commenting on reports that the company did not appropriately disclose safety information about its lead drug candidate obeticholic acid (OCA), but Intercept released a set of e-mail messages on 22 May that show the company knew about OCA's impacts on cholesterol in the investigator-sponsored FLINT trial as early as 6 January.

OCA's effects on lipid levels in nonalcoholic steatohepatitis (NASH) patients were not unexpected, since diabetes and cardiovascular disease are common...

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