Eli Lilly and Boehringer Ingelheim said Wednesday that an FDA advisory committee has voted 14 to 2 that the benefits of empagliflozin do not outweigh the risks to support approval as an adjunct to insulin for adults with type 1 diabetes. The panel members suggested there was a need for at least one additional study, with a larger sample size, to determine safety risks for the SGLT-2 inhibitor.
The drug is currently approved in the US under the name Jardiance for adults with type 2 diabetes, and has also been cleared to lower the risk of cardiovascular death in type 2 diabetes patients with cardiovascular disease.
Mohamed Eid, head of clinical development and medical affairs at Boehringer Ingelheim, said "we continue to believe the totality of data from the EASE programme indicates a favourable benefit-risk profile for empagliflozin 2.5 mg in adults with type 1 diabetes." Boehringer Ingelheim has proposed a 2.5-mg dose of empagliflozin for use in type 1 diabetes to help lower the risk of diabetic ketoacidosis. Eid stated that the companies will "[continue] to work with the FDA in this review process."
The filing contained data from the Phase III EASE programme, including the EASE-3 trial, which found that the 2.5-mg dose of empagliflozin in combination with insulin reduced HbA1C levels in adults with type 1 diabetes by a significant 0.28%, compared with insulin when given with a matched placebo. Secondary objectives of the trial demonstrated reductions in weight of 1.8 kg and systolic blood pressure of 2.1 mmHg for empagliflozin-treated patients, versus insulin plus placebo. The companies noted that adverse events occurred with similar frequency between the two groups, while the number of diabetic ketoacidosis events was "comparable."
In July, the FDA rejected AstraZeneca's filing to expand the label for its SGLT-2 inhibitor Farxiga (dapagliflozin) for use in adults with type 1 diabetes. Although the once-daily oral therapy has been approved in this indication in Europe and Japan under the name Forxiga.
Meanwhile, the increased risk of diabetic ketoacidosis was highlighted during the FDA review process for Sanofi and Lexicon Pharmaceuticals' Zynquista (sotagliflozin), a dual inhibitor of SGLT1 and SGLT2, following which the US regulator declined to approve the treatment. Sanofi recently ended a partnership with Lexicon on the drug.
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