Merck Gets FDA Warning Letter on Drug Study

Merck Gets FDA Warning Letter on Drug Study

March 1st, 2012 // 1:53 pm @

FDA said Merck & Co . failed to meet a requirement to conduct a safety study in rodents of its blockbuster diabetes drug Januvia.

The FDA issued a warning letter to Merck on Feb. 17, saying Merck was months late in submitting information about the required study to the agency. The FDA instructed Merck to submit a final study design within 30 days to address the requirement.

“This violation is concerning from a public health perspective because” the required 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 FDA said in its letter, which was posted on its website Tuesday.

Pancreatitis is an inflammation of the pancreas. The FDA-approved prescribing label for Januvia noted that there have been reports of acute pancreatitis in Januvia users, and that patients should stop taking the drug if the condition is suspected.

Merck, in a written statement posted online Tuesday, said it would submit a final protocol for the required study to the FDA for review within 30 days and will start the study within six months. Merck said it would revise its proposal as necessary to gain the FDA’s agreement.

“Merck remains fully committed to completing this requirement,” the company said. “Merck takes its responsibility to comply with FDA regulations very seriously, and is thoroughly reviewing its processes and procedures to ensure that Merck fulfills its commitments to the FDA going forward.”

In its warning letter, the FDA said that, in 2009, the agency told Merck it was required to conduct a three-month pancreatic safety study in a diabetic-rodent model treated with sitagliptin. Sitagliptin is the active ingredient in Januvia, and is also found in a related Merck diabetes drug, Janumet.

The requirement was included by the FDA as part of its February 2010 approval of supplemental new-drug applications for Januvia and Janumet. The required study was to have been completed and submitted to the FDA by June 15, 2011, Merck said.

According to the FDA, Merck proposed such a study, but the FDA identified certain deficiencies in it. The FDA said Merck proceeded to miss various milestones in meeting the requirement.

While Merck submitted data from an independent, 12-month study in mice, the FDA said the submission didn’t meet its requirements, and told Merck to conduct a three-month rodent study.


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