BI/Lilly's Jardiance Is First Diabetes Drug With CV Benefit Claim
Companies are supporting new US-labeled indication for cardiovascular mortality risk reduction with a consumer education campaign, direct-to-consumer advertising and cardiologist detailing.
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Boehringer wants supplemental empagliflozin claim as insulin adjunct to improve glycemic control in type 1 diabetes, but US FDA questions the size of the clinical benefit and the magnitude of a diabetic ketoacidosis risk.
Farxiga, with a new indication to prevent hospitalization for heart failure in type 2 diabetes patients, is the first drug among the SGLT2 class to gain this indication outside of diabetics with renal disease.
The German group's pharma chief told Scrip that he does not expect to see any competition in the US in the short term to the soon-to-be off-patent COPD blockbuster, citing the complicated case of GSK's Advair for which there are still no FDA approved generics despite losing exclusivity a while ago.