FDA Nixes Merck’s Request To Have Januvia Cardio Safety Data On Its Label

Written by Arsalan Arif (ENDpts.com)

The Merck & Company, Inc. (NYSE:MRK) flagship DPP-4 diabetes drug Januvia, a $6 billion earner last year, came out of a massive 14,724-patient study in 2015 with data demonstrating that Type 2 patients could take this drug without raising their risk for cardio complications. Merck wanted that in the label to help distinguish themselves from same-class rivals like Onglyza, which has risks, but the FDA has nixed the idea, handing the pharma giant a complete response letter.

...That has to be a bitter disappointment to Merck. Some solidly pro-Merck analysts like Tim Anderson were quick to give the TECOS cardio data a big thumbs up, estimating that it could swell revenue from the franchise drug by 10% by 2020. So far, though, instead of increasing, Januvia revenue has flattened out after SGLT2 drugs came along, GLP-1 drugs gained traction and new safety warnings hit the DPP-4 class.

Merck did not have a lot to say about it in their brief announcement this morning. Merck is reviewing the letter and will discuss next steps with the FDA.

Sales groups for AstraZeneca’s (NYSE:AZN) Onglyza (saxagliptin) and Takeda’s Nesina have had to grapple with distinct evidence of safety risks, a tough rap to beat in the ultra competitive diabetes market, where marketers take advantage of everything they can reasonably lay their hands on.