Lilly & BI’s Jardiance (empagliflozin) approved in the EU – May 23, 2014

Today, Lilly/BI announced the European approval of the SGLT-2 inhibitor empagliflozin (brand name: Jardiance) for type 2 diabetes as monotherapy or as an add-on to other glucose-lowering drugs, including insulin (consistent with the label for J&J’s Invokana and AZ’s Forxiga). This approval follows a positive EU CHMP opinion delivered in March (read our report). At the time of publication, the EMA had not posted Jardiance’s label online. We imagine there will be some restriction suggested in people with renal impairment, and the question is where the threshold will be. In the US, empagliflozin received an FDA Complete Response Letter in March (read our report) due to deficiencies at BI’s manufacturing facility. It appears that those issues have been addressed, as during Lilly’s 1Q14 update, company management indicated that FDA action on empagliflozin is still possible in 2014 (a mid-year re-filing and a shortened review cycle could make that a reality). Jardiance will be the third drug to market in the SGLT-2 inhibitor class in Europe (and possibly the US), but the class is still relatively young, with plenty of room for growth all around. Lilly/BI have previously stated that empagliflozin is significantly more selective for the SGLT-2 receptor than Invokana or Forxiga, but we have yet to see strong evidence of a resultant clinically meaningful difference – the most potent differentiating factor may end up being price. As a reminder, the FDA accepted Lilly/BI’s New Drug Application for an empagliflozin/linagliptin fixed-dose combination last month (read our report), exciting news given the possible synergism between the two drug classes – see our report on recently disclosed solid topline phase 3 data on AZ’s saxagliptin/dapagliflozin combination. Another exciting avenue for SGLT-2 inhibitors is their use in type 1 diabetes – we saw data from a proof-of-concept study of empagliflozin in type 1 diabetes presented at last year’s EASD (read our coverage; mean 0.4% A1c reduction from 8.0% baseline, less symptomatic hypoglycemia and lower insulin requirements), and AZ recently announced that it would be moving Forxiga into a phase 3 trial in type 1 diabetes later this year.