Lilly and Boehringer Ingelheim Submit a New Drug Application for Empagliflozin to the FDA

On March 25, Lilly and Boehringer Ingelheim (BI) announced that they submitted an application to the FDA for empagliflozin, an SGLT-2 inhibitor, for type 2 diabetes. This drug is in the same class as Janssen’s Invokana (canagliflozin), which was recently approved by the FDA and is now available in the US (see www.invokana.com). Earlier in January, Lilly/BI had announced positive results for four completed phase 3 studies of empagliflozin. The drug significantly reduced A1c – we’re still waiting to find out from Lilly/BI the phase 3 trial full results – and had an acceptable safety profile, though the drug has increased rates of genital infections compared to placebo as other SGLT-2 inhibitors do. By the time Lilly/BI finishes the phase 3 program, the company will have results from 14,500 participants from eight different countries. Some of the more interesting trials tested empagliflozin in combination with other diabetes medications. For instance, empagliflozin was combined with Lilly/BI’s Tradjenta (linagliptin), a DPP-4 inhibitor. DPP-4 inhibitors decrease blood glucose levels with a low risk of hypoglycemia and are weight neutral. A combination drug with empagliflozin could have effective blood glucose-lowering effects without a significant risk of hypoglycemia. The FDA normally takes one year to review a drug, meaning empagliflozin could be approved in March 2014. Please read our learning curve on this new drug class for more about SGLT-2 inhibitors. –MN