March 20, 2020
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FDA rejects lower-dose empagliflozin 2.5 mg for type 1 diabetes

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The FDA on Friday issued a complete response letter for a supplemental new drug application for a 2.5 mg dose of the SGLT2 inhibitor empagliflozin as an adjunct to insulin for adults with type 1 diabetes, according to a press release from Boehringer Ingelheim and Eli Lilly.

The FDA issues a complete response letter to an applicant if the agency determines that it will not approve the application or abbreviated application in its present form for one or more reasons. As Healio previously reported, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-2 in November against recommending approval of a supplemental NDA for empagliflozin 2.5 mg as an oral medication adjunct to insulin therapy for adults with type 1 diabetes. Committee members cited uncertainty regarding the adjudication of diabetic ketoacidosis (DKA) and a lack of adequate data to support evidence for safety and efficacy.

The proposed dose is lower than currently approved 10 mg and 25 mg doses of empagliflozin (Jardiance) for type 2 diabetes.

“The challenges of managing blood sugar levels for those with type 1 diabetes, and the desire for new treatment options, reveal important unmet needs in the diabetes community,” Mohamed Eid, MD, MPH, MHA, vice president of clinical development and medical affairs, cardio-metabolism and respiratory medicine at Boehringer Ingelheim, said in the release. “We remain committed to the continued study of therapies that may improve outcomes for adults with cardiorenal metabolic conditions, including diabetes.”

U.S. Food and Drug Administration 
The FDA on Friday issued a complete response letter for a supplemental new drug application for a 2.5 mg dose of the SGLT2 inhibitor empagliflozin as an adjunct to insulin for adults with type 1 diabetes, according to a press release.
Source: FDA

Insulin and pramlintide (Symlin, AstraZeneca) are the only drugs currently approved for the treatment of type 1 diabetes in the United States, and other noninsulin therapies have met similar hurdles with the FDA. In March 2019, the FDA issued a complete response letter regarding an NDA for oral sotagliflozin (Zynquista, Sanofi and Lexicon), a first-in-class dual SGLT1 and SGLT2 inhibitor for adults with type 1 diabetes, also citing a potential increased risk for DKA. – by Regina Schaffer

Disclosure: Eid is vice president of clinical development and medical affairs, cardio-metabolism and respiratory medicine at Boehringer Ingelheim.