US FDA issues CRL for empagliflozin for adults with type 1 diabetes
The US Food and Drug Administration has issued a complete response letter (CRL) for the supplemental New Drug Application (sNDA) of the investigational drug empagliflozin 2.5mg as an adjunct to insulin for adults with type 1 diabetes.
Empagliflozin 2.5mg is being developed by family-owned German drugmaker Boehringer Ingelheim and US pharma major Eli Lilly (NYSE: LLY). The CRL should come as no surprise, given that last November an FDA advisory panel voted against the use of the already approved diabetes drug (trade name Jardiance, with sales of $944 million post by Lilly for 2019) as an add-on to insulin therapy in patients with type 1 diabetes, citing a lack of adequate data to support evidence for safety and efficacy.
Lilly plunges on the news
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