No surprise: After near unanimous adcomm, FDA rejects Eli Lilly bid to bring Jardiance to type 1 patients
In an unsurprising move, the FDA has rebuffed Eli Lilly and Boehringer Ingelheim in their efforts to expand the indication for their best-selling diabetes drug Jardiance, issuing a complete response letter.
The CRL came four months after an FDA advisory committee voted 14-2 against allowing the two drugmakers to market the drug for type 1 diabetes, saying the risks outweighed the potential benefits. The FDA does not publicly release its rejection letters, but in a press release, Eli Lilly acknowledged the ruling was “consistent with the outcome of the Endocrinologic and Metabolic Drugs Advisory Committee in November.”
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