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

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    graham64
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    FDA nixes Merck’s shot at getting Januvia cardio safety data onto the label

    Post by graham64 on Fri Apr 07 2017, 22:08

    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.

    https://endpts.com/fda-nixes-mercks-shot-at-getting-januvia-cardio-safety-data-onto-the-label/

    Check out the response letter in the link


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    chris c
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    Re: FDA nixes Merck’s shot at getting Januvia cardio safety data onto the label

    Post by chris c on Sun Apr 09 2017, 23:21

    Sounds really healthy stuff doesn't it?

      Current date/time is Thu Jul 27 2017, 15:35