Tag Archives: Janssen

FENIX Analysis: Invokana CREDENCE Promotion

Yesterday, Janssen announced FDA approval of the Invokana renal protection indication based on results from the CREDENCE trial. Following the approval, Janssen has already updated the Invokana patient and HCP websites with CREDENCE being front and center. Below, FENIX analyzes the updated messaging and provides insights into the impending field launch for the new renal protection indication.

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CREDENCE Label Update for Invokana is a Big Win for Janssen

Janssen announced FDA approval of a new Invokana indication to reduce the risk of kidney disease, CV death, and heart failure hospitalizations in T2DM patients who have diabetic nephropathy with albuminuria. Recall, FDA granted priority review to the CREDENCE sNDA shortening the review time to 6 months. CREDENCE is the second first-pass priority review approval in a row for diabetes following Novo’s Rybelsus (oral semaglutide) on Sept 20. Below, FENIX provides thoughts on the new indication and SGLT2i market implications with special attention to the Invokana HF indication.

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Invokana CREDENCE Filing Accepted by EMA; Dexcom Wins Patent Dispute with AgaMatrix

Last week, two key news items were observed including the Invokana CREDENCE EMA filing acceptance and resolution to the Dexcom/AgaMatrix patent dispute litigation. Below, FENIX provides context and analysis for these announcements.

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