FDA Approves Once-Daily Xigduo XR – Fixed Dose Combination of Metformin + SGLT-2 Inhibitor

Twitter summary: FDA approves Xigduo XR – first once-daily SGLT-2 inhibitor/metformin fixed dose combo in the US

AstraZeneca recently announced that the FDA approved Xigduo XR, a once-daily fixed-dose combination pill (that means two pills in one) of the SGLT-2 inhibitor Farxiga (dapagliflozin) and metformin extended release. Xigduo XR is approved for adults with type 2 diabetes to be taken in addition to diet and exercise to help improve glycemic control. Xigduo XR is the first once-daily SGLT-2 inhibitor/metformin combination pill available in the US. Janssen’s Invokamet, a twice-daily SGLT-2 inhbitor/metformin combination pill, was approved this past September. No pricing or reimbursement information for Xigduo XR is available at this time but we’re pretty sure it will be around the same price as what one pill costs that isn’t a combination.

As a reminder, SGLT-2 inhibitors are a class of drugs that lower glucose levels by causing the kidney to excrete excess glucose through urine. They reduce A1c, cause very little hypoglycemia (none for most people), and can lead to weight loss and improvement in blood pressure. There are currently three SGLT-2 inhibitors available in the US: Janssen’s Invokana, AstraZeneca’s Farxiga (dapagliflozin), and Boehringer Ingelheim and Lilly’s Jardiance (empagliflozin). Metformin, on the other hand, is a widely used treatment for type 2 diabetes known for its efficacy, safety, low cost, ease of use, and potential anti-cancer properties.

Combination pills such as Invokamet and Xigduo have an important convenience advantage for patients, since they reduce the burden of filling multiple prescriptions, taking multiple pills, and could potentially lower co-pays as well. Xigduo is a step forward, particularly given its once-daily dosing. Down the road, SGLT-2 inhibitor/DPP-4 inhibitor combination pills will also be an important innovation in type 2 diabetes drugs – these medications will combine two effective therapies that don’t cause hypoglycemia and don’t cause weight gain. One such drug, a combination of Jardiance (empagliflozin) and Tradjenta (linagliptin), is currently under FDA review and could receive approval in early/mid 2015 at the soonest – now this combination could be truly exciting, and its (hopeful) approval is really widely awaited. –AJW/KC