Commercialization, FDA

FDA nixes Merck’s shot at getting Januvia cardio safety data onto the label

Merck is not going to get any help from the FDA in marketing its big diabetes drug Januvia.

A $6 billion earner last year, Merck’s flagship DPP-4 drug 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 nixed the idea, handing the pharma giant a complete response letter.

The CRL covered Januvia as well as its combos with metformin.

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.

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

Image: Shutterstock

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