The U.S. Food & Drug Administration has hit Merck & Co. with a warning letter for its failure to conduct a safety study of its type 2 diabetes drug, Januvia. The study, which was to be conducted with rodents, was meant to assess Januvia’s association with pancreatitis.
Januvia’s label already warns that acute pancreatitis is a possible side effect of the drug, In the warning letter, the FDA says that it informed Merck in 2009 was required to conduct a three-month pancreatic safety study in a diabetic-rodent model treated with sitagliptin, the active ingredient in Januvia.
The requirement was included by the FDA as part of its February 2010 approval of supplemental new-drug applications for Januvia and Janumet, another sitagliptin-containing medication made by Merck.
The FDA said the submission didn’t meet its requirements
While Merck submitted data from an independent, 12-month study in mice, the FDA said the submission didn’t meet its requirements, and ordered the three month study. A study proposed by Merck was found to be deficient by the FDA.
The study was “part of a written agreement between you and the FDA to conduct additional testing to further assess a signal of a serious risk of acute pancreatitis…associated with the use” of Januvia, the warning letter states.
The FDA warning letter gives the drug maker 30 days to submit a final study design within 30 days to address the requirement.
According to a report from The Wall Street Journal, Merck issued a statement on its website stating it would submit a final protocol for the required study to the FDA within 30 days and will start the study within six months.