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BI/Lilly’s SGLT-2 Inhibitor Jardiance (empagliflozin) resubmitted to the FDA

Published: 7/1/14

On June 17, Boehringer Ingelheim (BI) and Lilly announced the resubmission to the FDA of the SGLT-2 inhibitor Jardiance (empagliflozin) for the treatment of type 2 diabetes. In this particular case, the FDA review process is expected to take about two months. Most expect the drug to be approved, as the FDA has not requested an advisory committee, and two other drugs – Janssen’s Invokana and AstraZeneca’s Farxiga – of the same class have already been approved by the Agency. When BI/Lilly first submitted Jardiance to the FDA in 2013, the FDA found no problems with the drug’s efficacy or safety, but submission had been denied because of an issue with the drug’s manufacturing plant. The FDA cleared the plant on June 3 of this year.

SGLT-2 inhibitors are a relatively new class of diabetes drugs that work by allowing glucose to be excreted through the urine (learn more in our learning curve on SGLT-2 inhibitors here). Interest in this drug class has grown dramatically since last year, and the future looks encouraging as companies are working on combining these drugs with other type 2 therapies (e.g., metformin, DPP-4 inhibitors), and many are investigating the potential of SGLT-2s in type 1 diabetes. –AJW

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