Boehringer Ingelheim — Jardiance FDA Review (NDA204629, SUPPL 5, 2016)

Boehringer Ingelheim · 2016 · FDA Review (openFDA)

Report summary

The FDA approved Boehringer Ingelheim's Jardiance (empagliflozin) on March 18, 2016, for improving glycemic control in adults with type 2 diabetes. This approval, supported by Study 1276.1, includes new information on efficacy and safety, particularly for combination therapies with metformin. Jardiance effectively reduces HbA1c, fasting plasma glucose, and body weight as monotherapy and in combination with other antidiabetic agents. While combination therapy generally showed superior HbA1c reduction, empagliflozin monotherapy was inferior to metformin monotherapy in some cases. Warnings include risks of ketoacidosis, renal impairment, urosepsis, hypoglycemia, and genital mycotic infections. Post-marketing surveillance and preclinical studies confirm its SGLT2 inhibition mechanism and consistent safety profile, with no new safety signals identified.

Key findings — cited to the page

M688/1, M380/1, M464/1 production in male kidneys	10-20 %	· p.247
M688/1, M380/1, M464/1 production in female kidneys	less than 10 %	· p.247
HbA1c reduction relative to placebo	-0.7	· p.34
Ketoacidosis incidence for empagliflozin 25 mg QD	0 %	Study 1276.1 · p.55
Body weight change from baseline	-1.95 kg	· p.33
Body weight change from baseline	-2.04 kg	· p.33
Difference in HbA1c from placebo (adjusted mean)	-0.5 %	· p.33
FPG change from baseline (adjusted mean)	-10.1 mg/dL	· p.32
Difference in HbA1c from placebo (adjusted mean)	-0.4 %	· p.33
Ketoacidosis incidence for empagliflozin 5 mg / metformin 500 mg BID	0 %	Study 1276.1 · p.55
Patients achieving HbA1c <7%	6.7 %	· p.32
HbA1c reduction relative to placebo	-0.4	· p.34

Source: Boehringer Ingelheim ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →