Merck’s Januvia Receives CRL from FDA for TECOS

Merck has announced it received a complete response letter (CRL) regarding its submission of data from the TECOS cardiovascular outcomes trial for Januvia (sitagliptin). The company has not disclosed the reason for the CRL, but said it is working with FDA to discuss next steps.

About The Author

Matthew Maryniak

President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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