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Boehringer, Lilly resubmit empagliflozin application
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Boehringer Ingelheim and Eli Lilly and Company announced they have resubmitted the application for type 2 diabetes investigational drug empagliflozin.
After receiving a response letter in March from the FDA regarding “deficiencies” found at the Boehringer Ingelheim facility where empagliflozin was being manufactured, the two companies filed the class 1 resubmission. The FDA response at that time required no additional clinical testing for the drug, a sodium-glucose cotransporter 2, which had been involved in more than 10 multinational clinical trials with more than 13,000 participants with type 2 diabetes.
“We are very pleased to move forward with resubmission of the empagliflozin [new drug application] following a FDA inspection of the Boehringer Ingelheim facility referenced in the complete response letter,” Paul Fonteyne, president and CEO of Boehringer Ingelheim, said in a press release. “We believe in the potential of empagliflozin and hope to provide another treatment option in the near future to adults with type 2 diabetes.”