Eli Lilly and Boehringer Ingelheim's SGLT2 med Jardiance has had a tough fight in Type 2 diabetes against competitors from AstraZeneca and Johnson & Johnson. The partners hoped they could take Jardiance into Type 1 under a different brand name to get a leg up, but now those hopes appear dashed.
The FDA on Friday issued a complete response letter to Eli Lilly and Boehringer Ingelheim rejecting the 2.5-milligram dose of empagliflozin on top of insulin to treat patients with Type 1 diabetes, Lilly said in a release. The decision will block Lilly and Boehringer from reaching the 40,000 new U.S. Type 1 diabetes patients diagnosed each year.
"We remain committed to the continued study of therapies that may improve outcomes for adults with cardiorenal metabolic conditions, including diabetes," Mohamed Eid, Boehringer's vice president of clinical development medical affairs for cardio-metabolism and respiratory medicine, said in a release.
The agency's move isn't all that surprising. In November, an FDA advisory committee voted 14-2 against empagliflozin––marketed as Jardiance in its Type 2 diabetes indications––on a lack of clinical data.
The committee reviewed results from the phase 3 Ease trial, which showed empagliflozin and insulin provided a significant reduction in A1C versus a placebo-insulin pair in adults with Type 1 diabetes, Boehringer said. The drug also hit its secondary endpoints of reducing patients' weight and systolic blood pressure with a comparable safety profile to the placebo control.
But in a briefing for the committee, Lisa Yanoff, acting director of the FDA's endocrinologic and metabolic drugs committee, noted that Lilly and Boehringer's submission relied on a single phase 3 trial with a relatively small patient pool and short duration.
Despite the drugmakers' finding that empagliflozin did not show a significantly higher rate of diabetic ketoacidosis over placebo, Yanoff said the trial's limitations may have suppressed the SGLT2 class's observed rate of higher diabetic ketoacidosis occurrence.
But things aren't all bad for Lilly and Boehringer as Jardiance looks to pick up additional indications in its heated battle for SGLT2 supremacy with AstraZeneca's Farxiga and Johnson & Johnson's Invokana.
Earlier this month, the FDA granted Jardiance a speedy review to reduce kidney disease progression and cardiovascular death in patients with chronic kidney disease (CKD). CKD is the ninth-leading cause of death in the U.S. and affects around 30 million Americans each year, Lilly said.
The FDA will base its review on results from the ongoing Empa-Kidney study, which is examining Jardiance's effect on the progression of kidney disease and the occurrence of CV death in adults with established chronic kidney disease both with and without diabetes.
Invokana scored an FDA nod in September to treat diabetic kidney disease and reduce the risk of hospitalization for heart failure in patients with Type 2 diabetes and diabetic kidney disease. A month earlier, AstraZeneca secured its own FDA fast track designation to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease.