Merck’s Januvia and Janumet Misbranded, FDA Says

Merck’s Januvia and Janumet Misbranded, FDA Says

February 29th, 2012 // 2:17 pm @

Source: Pharmalot

The FDA has decided that the Januvia and Janumet diabetes meds sold by Merck are misbranded, because the drugmaker failed to submit an agreed-upon post-marketing study, which the agency had required to assess the risk of acute pancreatitis. The disclosure came in a warning letter that the FDA sent to Merck in which the agency notes the drugmaker is 20 months late in meeting a timetable.

Why were post-marketing studies required? You may recall that, in 2009, the FDA revised prescribing information for the drugs to include information on 88 cases of acute pancreatitis between Oct. 16, 2006 and Feb. 9, 2009. Januvia, by the way, is also known as sitagliptin; Janumet combines this drug with metformin and, at the time, these were the first in a new type of diabetes med (read here).

Here is the background: the FDA sent Merck a complete response letter in October 2009 to say that scrutinizing adverse events reports would not be sufficient to gauge the risk of acute pancreatitis and that, instead, a three-month pancreatic safety study in a diabetic rodent model treated with sitagliptin would be required.

A timetable was established and Merck was required to submit a final protocol by June 15, 2010; followed by a study completion date on March 15, 2011, and a final report submission on June 15, 2011. Completing the three-month study was specified as a condition for supplemental new drug approvals from the FDA.

But Merck repeatedly blew past the deadlines. Moreover, the drugmaker proposed to satisfy the post-marketing requirement by submitting study data from another independently conducted investigator-initiated study, not the agreed-upon studies cited by the FDA. And even then, Merck was unable to meet deadlines for submitting information from this undertaking.

As recently as this past November, the FDA noted a Failure to Respond letter was issued and that Merck replied by including “a brief description of the protocol for the ongoing independent study and an interim report and tables of interim results,” the FDA wrote. Yet Merck still did not provide a final protocol submission for a new study that would fulfill the post-marketing requirements.

As of January 6, Merck submitted data from the now-completed proposed independent rodent study to the IND. “However,” the FDA noted, “this submission is not considered a final study report. Further, FDA has not been provided sufficient information to determine whether the proposed independent study is adequate to satisfy” the post-marketing requirements.

“Therefore, you have submitted neither a study protocol for a new rodent study, nor a final study report for the independent study that you proposed would satisfy the PMRs,” the FDA continues. “You have not provided an adequate explanation for the cause of the delay of either of the milestones in the timetable for completion of the postmarketing requirement, nor did you propose to revise the agreed-upon timeline.”

“As a result, you are more than 20 months late in achieving the June 15, 2010 final protocol submission milestone and more than 8 months late in achieving the final protocol submission milestone in the timetable, and you have not demonstrated good cause for these delays,” the agency writes. As a result, “your product is considered misbranded because you are in violation of a postmarketing requirement (PMR)…”

If Merck does not get its act together, however, the FDA could levy a $250,000 fine for each violation.

In response, Merck issued this statement: “Merck is fully committed to complying with FDA’s requirement and is confident that the company will complete the requirement within the time frame outlined in the February 17 letter. Specifically, Merck will submit a final protocol for a new rodent study to FDA for review within 30 days of the date of the letter, revise it as necessary to gain FDA’s agreement on the new study, and start the study within 6 months. Merck is preparing its response to the FDA now, including the design of the new study.” Here is the FDA warning letter.

However, there was no explanation as to why Merck failed to meet the deadlines or submitted the independent study protocol instead of the agreed-upon information.

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