MediLexicon Logo
MediLexicon Logo
Abbreviations        Abbrev Definitions        Dictionary        ICD Codes        Equipment        Hospitals        Drugs        More..
  


Farxiga (dapagliflozin)

Company: Bristol-Myers Squibb
Approval Status: January of 2014
Treatment for: type II diabetes
Areas: Diabetes / Endocrinology

| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |


General Information

Farxiga (dapagliflozin) is an orally active sodium glucose cotransporter type 2 (SGLT-2) inhibitor. Inhibiting SGLT2 activity modulates reabsorption of glucose in the kidney, resulting in excretion of glucose in the urine.

Farxiga is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus.

Farxiga is supplied as a tablet for oral administration. The recommended starting dose is 5 mg once daily, taken in the morning, with or without food. The dose can be increased to 10 mg once daily in patients tolerating Farxiga who require additional glycemic control. Renal function should be assessed before initiating Farxiga. Do not initiate Farxiga if eGFR is below 60 mL/min/1.73 m2. Farxiga should be discontinued if eGFR falls persistently below 60 mL/min/1.73 m2.


Clinical Results

FDA Approval
The FDA approval of Farxiga was based on monotherapy and combination studies, when combined with metformin, pioglitazone, glimepiride, sitagliptin (with or without metformin), or insulin (with or without other oral antidiabetic therapy).
Monotherapy Studies
Two placebo controlled studies were conducted in 840 treatment-naive subjects with inadequately controlled type II diabetes. One of these was a 24-week study in 558 subjects. Following a 2-week diet and exercise placebo lead-in period, 485 subjects with HbA1c >7% and <10% were randomized to Farxiga 5 mg or 10 mg once daily in either the morning (QAM, main cohort) or evening (QPM), or placebo. At Week 24, treatment with Farxiga 10 mg QAM provided significant improvements in HbA1c and FPG compared with placebo. Change from baseline in HbA1c for Farxiga: -.9 vs. placebo: -.2; change from baseline in FPG for Farxiga: -28.8 vs. placebo: -4.1.
Combination Therapy Studies
The combination treatment of Farxiga 10 mg plus metformin XR provided statistically significant improvements in HbA1c and FPG compared with either of the monotherapy treatments and statistically significant reduction in body weight compared with metformin XR alone. Farxiga 10 mg as monotherapy also provided statistically significant improvements in FPG and statistically significant reduction in body weight compared with metformin alone and was noninferior to metformin XR monotherapy in lowering HbA1c. The combination treatment of Farxiga 5 mg plus metformin XR provided statistically significant improvements in HbA1c and FPG compared with either of the monotherapy treatments and statistically significant reduction in body weight compared with metformin XR alone. As add-on treatment to metformin, Farxiga 10 mg provided statistically significant improvements in HbA1c and FPG, and statistically significant reduction in body weight compared with placebo at Week 24 Statistically significant (p<0.05 for both doses) mean changes from baseline in systolic blood pressure relative to placebo plus metformin were -4.5 mmHg and -5.3 mmHg with FARXIGA 5 mg and 10 mg plus metformin, respectively. Farxiga led to a similar mean reduction in HbA1c from baseline at Week 52 (LOCF), compared with glipizide, thus demonstrating noninferiority . Farxiga treatment led to a statistically significant mean reduction in body weight from baseline at Week 52 (LOCF) compared with a mean increase in body weight in the glipizide group. Statistically significant (p<0.0001) mean change from baseline in systolic blood pressure relative to glipizide plus metformin was -5.0 mmHg with Farxiga plus metformin. In combination with glimepiride, Farxiga 10 mg provided statistically significant improvement in HbA1c, FPG, and 2-hour PPG, and statistically significant reduction in body weight compared with placebo plus glimepiride at Week 24. In combination with pioglitazone, treatment with Farxiga 10 mg provided statistically significant improvements in HbA1c, 2-hour PPG, FPG, the proportion of patients achieving HbA1c <7%, and a statistically significant reduction in body weight compared with the placebo plus pioglitazone treatment groups. In combination with sitagliptin (with or without metformin), Farxiga 10 mg provided statistically significant improvements in HbA1c, FPG, and a statistically significant reduction in body weight compared with the placebo plus sitagliptin (with or without metformin) group at Week 24. When combined with insulin, at Week 24, Farxiga 10 mg dose provided statistically significant improvement in HbA1c and reduction in mean insulin dose, and a statistically significant reduction in body weight compared with placebo in combination with insulin, with or without up to 2 OADs; the effect of Farxiga on HbA1c was similar in patients treated with insulin alone and patients treated with insulin plus OAD. Statistically significant (p<0.05) mean change from baseline in systolic blood pressure relative to placebo in combination with insulin was -3.0 mmHg with Farxiga 10 mg in combination with insulin. At Week 24, Farxiga 5 mg (-5.7 IU, difference from placebo) and 10 mg (-6.2 IU, difference from placebo) once daily resulted in a statistically significant reduction in mean daily insulin dose (p<0.0001 for both doses) compared to placebo in combination with insulin, and a statistically significantly higher proportion of patients on Farxiga 10 mg (19.6%) reduced their insulin dose by at least 10% compared to placebo (11.0%).


Side Effects

Adverse events associated with the use of Farxiga may include, but are not limited to, the following:

  • female genital mycotic infections
  • nasopharyngitis
  • urinary tract infections


Mechanism of Action

Farxiga (dapagliflozin) is an inhibitor of Sodium-glucose cotransporter 2 (SGLT2). SGLT2 is expressed in the proximal renal tubules and is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.


Additional Information

For additional information regarding Farxiga or type II diabetes, please visit the Farxiga web page.




< back to top

Farxiga Drug Information

The Farxiga drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.





MediLexicon International Ltd Logo

Privacy Policy   |    Disclaimer   |    Contact / Feedback

MediLexicon International Ltd
Bexhill-on-Sea, UK
MediLexicon International Ltd © 2004-2014 All rights reserved.