Memorandum

Lilly and BI resubmit FDA NDA for SGLT-2 inhibitor Jardiance (empagliflozin) – June 17, 2014

Earlier today BI/Lilly announced that they have made a Class 1 resubmission of Jardiance (empagliflozin) to the FDA. Our understanding is that a Class 1 resubmission entails a two-month review process from the day the FDA receives the NDA. As background, BI/Lilly originally filed empagliflozin in the US in 2013; however, the FDA issued a Warning Letter in May 2013 regarding BI’s manufacturing plant Ingelheim, Germany for the agent. The letter cited the appearance of large particles contaminating a batch of active ingredient being manufactured at the plant. In March 2014, the FDA issued a complete response letter (CRL) for the agent, because the issue had not been resolved. No new clinical trials were requested, and the FDA did not take issue with any aspect of the drug’s efficacy or safety to our knowledge. On June 3, BI announced that the FDA has cleared the manufacturing plant. As a reminder, Jardiance recently received EU approval, making it the third SGLT-2 inhibitor to the global market (after AZ’s Forxiga and J&J’s Invokana). We recently saw long-term follow up on phase 3 data for empagliflozin at ADA 2014 Day #4 where it demonstrated better glycemic efficacy over Merck’s Januvia and the SFU glimepiride.