FDA Approves Another SGLT2 Inhibitor for Treating CKD

The SGLT2 inhibitor empagliflozin (Jardiance) nabbed a new indication for the treatment of adults with chronic kidney disease (CKD) regardless of diabetes status, Boehringer Ingelheim and Eli Lilly announced.

Data from the phase III EMPA-KIDNEY trial paved the way for the approval, which found a 29% reduced risk for CKD progression compared with placebo (HR 0.71, 95% CI 0.62-0.81).

“This approval provides healthcare professionals in the U.S. with another treatment option for adults with CKD that can reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalizations,” said EMPA-KIDNEY steering committee member Katherine Tuttle, MD, of the University of Washington in Spokane, in a statement.

CKD progression in the study — defined as end-stage kidney disease, a sustained decrease in eGFR to less than 10 mL/min/1.73 m², a sustained decrease in estimated glomerular filtration rate (eGFR) of 40% or more, or death from renal causes — occurred in 11.6% of patients on empagliflozin versus 15.2% on placebo.

Those on 10 mg of the once-daily oral drug also saw a significantly lower risk for all-cause hospitalization, and placebo patients had a steeper decline in eGFR over the 2-year follow-up. Empagliflozin is also available in 25 mg daily doses for patients requiring additional glycemic control.

As detailed on the label, the drug is not indicated for type 1 diabetes or for those with an eGFR less than 30 mL/min/1.73 m². It’s also not recommended for CKD in patients with polycystic kidney disease or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease.

As expected for the the SGLT2 class, the most common adverse events with empagliflozin were urinary tract infections and yeast infections in women.

Empagliflozin was initially approved in 2014 to lower blood sugar along with diet and exercise in type 2 diabetes. The tablet subsequently picked up heart-related indications for the risk reduction of cardiovascular death and hospitalization for heart failure. Empagliflozin was also the first SGLT2 inhibitor to be approved for kids with type 2 diabetes earlier this year, making it the first oral option to be approved for this indication since metformin was approved for pediatric use in 2000.

The tablet follows in the footsteps of another SGLT2 inhibitor, dapagliflozin (Farxiga), which in 2021 picked up an indication for treating CKD regardless of diabetes status. The SGLT2 inhibitor canagliflozin (Invokana) carries an indication for preventing end-stage kidney disease, worsening renal impairment, cardiovascular death, hospitalization for heart failure, and diabetic nephropathy with albuminuria in adults with type 2 diabetes and diabetic kidney disease.

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