As expected, Eli Lilly (NYSE:LLY) has received a Complete Response Letter
(CRL) from the FDA regarding its marketing application seeking approval
to use Jardiance (empagliflozin) as an adjunct to insulin in adults
with type 1 diabetes. In November 2019, an advisory committee voted 14 – 2 against approval for the indication.
Jardiance was approved in August 2014 for adults
with type 2 diabetes. In December 2016, the FDA approved a
cardiovascular benefit claim in this population.
The company is co-developing the SGLT2 inhibitor with privately held Boehringer Ingelheim.
Shares down a fraction after hours.
https://seekingalpha.com/news/3553964-fda-rejects-lillys-jardiance-for-type-1-diabetes
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