Merck & Co dented by Januvia labeling denial

Shares in US pharma giant Merck & Co (NYSE: MRK) slipped in the morning’s trading on news that the US Food and Drug Administration (FDA) had issued a Complete Response Letter regarding the company’s Supplemental New Drug Applications for Januvia (sitagliptin) and its two Janumet (sitagliptin and metformin HCl) formulations.

Merck & Co had sought through these applications to include data from the TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) study, in the prescribing information of sitagliptin-containing medicines, with the study showing that their use did not raise the risk of cardiovascular complications among treated patients. They are prescribed for type 2 diabetes.

Januvia/Janumet was by far the company’s biggest selling product last year, raising $6.11 billion, and Merck had wanted this addition to the label to help distinguish themselves from rival drugs such as Onglyza (saxagliptin), a treatment marketed by Anglo-Swedish pharma major AstraZeneca (LSE: AZN) which has been linked to safety risks.