U.S. regulators have slapped Merck ($MRK) with a warning letter for dragging its feet in conducting a pancreatic safety study in rodents for its diabetes drug Januvia, a blockbuster product that has made billions for the drugmaker but also has been linked with a troubling safety issue.
Whitehouse Station, NJ-based Merck was supposed to have wrapped up the three-month safety study by June 15, 2011 as part of the FDA's post-marketing requirement in its February 2010 supplemental approval of Januvia and Janumet--which is a combo of Januvia's active ingredient sitagliptin and metformin. That didn't happen. In its Feb. 17 warning letter, the FDA told Merck to deliver a design for the rodent study within 30 days, and the pharma giant stated Tuesday that it plans to do just that and begin the testing within the next 6 months.
"This violation is concerning from a public health perspective because" the rodent 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 sitagliptin, the FDA said in its warning letter, as quoted by Dow Jones Newswires.
Regulators ordered the safety study after diabetics who had taken sitagliptin developed pancreatitis, an inflammation of the pancreas, including fatal and nonfatal cases. Merck tried to give the FDA a 12-month independent rodent study to satisfy the requirement, but regulators declined to accept those data in lieu of the three-month study. In the meantime, doctors are supposed to take patients off the med immediately if they show signs of pancreatitis, although it's unknown whether the drug causes increased risk of the condition in patients with a history of pancreatitis, according to the drug's label.
Reported cases of pancreatitis cropped up in 88 patients after they took the drug between Oct. 16, 2006, and Feb. 9, 2009, Bloomberg reported. Yet Januvia and Janumet have been among Merck's best-selling products, with sales of those two drugs alone hauling in $4.7 billion for the drug giant last year, Dow Jones reported.
The big bucks will likely continue to keep rolling in from sales of the two diabetes drugs during the time it will take to complete the study, likely dwarfing the fines that Merck faces related to the FDA warning. Bloomberg reported that the fines could hit $250,000, with other potential penalties on the table as well.