Memorandum

FDA clears Boehringer Ingelheim manufacturing plant – Lilly/BI may now move forward with Jardiance (empagliflozin) re-submission in the US – June 5, 2014

Boehringer Ingelheim (BI) announced on Tuesday that the FDA has cleared BI’s manufacturing plant in Ingelheim, Germany, which presumably means that Lilly/BI can soon re-submit their SGLT-2 inhibitor Jardiance (empagliflozin) in the US. As a reminder, this plant was the subject of a Warning Letter in May 2013, which 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 Jardiance  because the issue had not been resolved. BI’s announcement indicates that the FDA re-inspection took place in March 2014 and that it received clearance from the FDA on Monday, June 2, lifting the Warning Letter and allowing it to move forward with Jardiance’s regulatory review. The timeline for re-submission has not been disclosed; however, we imagine that Jardiance could undergo a shortened review process the second time around given that the manufacturing plant deficiencies were the only issue (to our knowledge) raised in the CRL, and there were no concerns with the safety or efficacy of the drug itself. 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).