The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the supplemental New Drug Application (sNDA) of empagliflozin 2.5mg (Boehringer Ingelheim and Lilly) as an adjunct to insulin for adults with type 1 diabetes.
The CRL notes that the “FDA is unable to approve the application in its current form, consistent with the outcome of the Endocrinologic and Metabolic Drugs Advisory Committee [EMDAC].” In November 2019, the FDA’s EMDAC voted 14 to 2 against the approval of empagliflozin 2.5mg stating that the risk/benefit profile of the drug does not support approval.
In meeting documents, the FDA panel pointed out limitations in the available safety and efficacy data submitted for review. Specifically, they noted that the applicants only submitted data from one phase 3 trial evaluating the 2.5mg dose (EASE-3), while another study (EASE-2) only evaluated higher doses of empagliflozin (10mg and 25mg).
Empagliflozin (Jardiance; Boehringer Ingelheim and Lilly), a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is currently approved for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) and also to reduce the risk of cardiovascular death in adult patients with T2DM and established cardiovascular disease.
The product is available in 10mg and 25mg strength tablets.
For more information visit beohringer-ingelheim.us or lilly.com.