- The FDA approves Eli Lilly (LLY +2.8%) and development partner Boehringer Ingelheim's Jardiance (empagliflozin) to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes and CV disease.
- The data supporting the new claim was generated in a large-scale post-marketing study involving more than 7,000 patients.
- The approval is a big win for the companies considering the close Ad Comm vote (12 - 11 in favor) in June.
- Novo Nordisk (NVO +0.7%) is close behind. It filed marketing applications in the US. and Europe in late October seeking approval of the same claim for Victoza (liraglutide).
- Previously: FDA Ad Comm to review Boehringer Ingelheim's applications for CV risk claims for diabetes meds (June 27)