Further evidence has come to light suggesting that GlaxoSmithKline knew about an increased cardiac risk with the diabetes drug rosiglitazone (Avandia) as early as 2001 but withheld the data and that certain officials at the FDA conspired with the company to minimize the impact of later safety results. The news comes on the same day that the FDA advisory panel starts its two-day hearing on the cardiovascular safety of the drug.
GSK announced that stepwise trial design of its losmapimod phase III study, LATITUDE-TIMI 60, an interim review of data from part A of the study (an initial cohort of 3,503 patients) did not indicate efficacy against the primary endpoint and did not support investment in the larger part B of the study as currently designed.
