FDA issues CRL on empagliflozin, noting manufacturing deficiencies

There was disappointment today for US drug major Eli Lilly (NYSE: LLY) and family-owned German pharma firm Boehringer Ingelheim when the US Food and Drug Administration issued a complete response letter for the New Drug Application of the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin.

The complete response letter referenced previously-observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. The FDA stated these deficiencies need to be resolved before the approval of the application. The FDA has not asked Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.

Companies will work with FDA to respond soonest