CREDENCE Receives Positive CHMP Opinion; Metformin ER Recalled Over NDMA Impurities

Two diabetes-related news items have been observed: according to the CHMP meeting highlights, Janssen’s Invokana/Vokanamet renal protection indication (CREDENCE) has received a positive CHMP opinion and FDA announced a voluntary recall for certain lots of metformin ER due to nitrosamine impurity N-Nitrosodimethylamine (NDMA) impurities. Of note, FDA indicated there are five firms who have been contacted about the recall but additional manufacturers remain unaffected. Below, FENIX provides brief thoughts on the the CREDENCE CHMP opinion and insight on a potential readthrough to branded OADs following the metformin recall.

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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