Merck warned over missing Januvia safety study
pharmafile | March 13, 2012 | News story | Research and Development | FDA, Januvia, Merck, study
Merck has been warned by the FDA that it must carry out a post-marketing safety study on diabetes treatments Januvia and Janumet.
The company had agreed to conduct the study and submit to the regulator in June 2011, but missed this deadline, and repeatedly failed to make good on its promises to supply other data.
The US regulator demanded the study to assess the risk of acute pancreatitis, after 88 cases were reported in patients taking the drug between October 2006 and February 2009.
The FDA stipulated that analysis of existing data would not be sufficient, and asked the firm to conduct a three-month pancreatic safety study in rodents. The FDA has warned Merck that its products are ‘misbranded’ because of its failure to comply with the post-marketing requirements.
The regulator says that if Merck fails to comply again, it could be fined up to $250,000 per violation and be subject to other measures. It added that other federal agencies may take this Warning Letter into account when considering the award of contracts.
Merck says it is confident that it will meet the new deadline for submitting the protocol, and begin the study within six months of this date. The company says it is preparing its response to the FDA now, including the design of the new study.
Merck eventually submitted a 12-month study in mice conducted by an independent researcher to the FDA, after much delay. But the FDA says this study does not satisfy the post-marketing requirement, and directed Merck to conduct a new three-month rodent study.
The combined sales of Januvia and Janumet in 2011 reached just under $4.9 billion making it a highly lucrative franchise. If the long-awaited rodent study does show up concerns about pancreatitis, the ramifications could be very serious for the company.
Merck said it was “thoroughly reviewing its processes and procedures” to ensure that Merck fulfils its commitments to the FDA in the future.
Andrew McConaghie
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