Janssen announced that the Food and Drug Administration (FDA) has approved Invokamet XR (canagliflozin, metformin HCl extended-release) for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes when treatment with the two medications is appropriate.
Current type 2 diabetes treatment guidelines from the AACE, ACE, and ADA recommend dual therapy for patients with initial A1c ≥7.5% and for those who have an initial level <7.5% and do not achieve an A1c treatment goal after 3 months on monotherapy. Dual or triple therapy is recommended as first-line therapy in asymptomatic patients with an initial A1c >9%.
Invokamet XR combines canagliflozin, a sodium glucose co-transporter (SGLT2) inhibitor, and metformin extended-release, a biguanide. Canagliflozin works with the kidneys to help patients lose some sugar through urination; metformin decreases glucose production in the liver and improves the body’s response to insulin. Clinical studies conducted in healthy adults showed that Invokamet XR resulted in the same levels of canagliflozin and metformin extended-release in the body as when the corresponding dosages of the two medicines were administered as separate tablets.
Invokamet (canagliflozin, metformin HCl), originally approved in August 2014, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes not adequately controlled with metformin or canagliflozin, or who are already being treated with both medications separately. Its indication was later expanded in May 2016 to include adults with type 2 diabetes who are not already being treated with canagliflozin or metformin and may benefit from dual therapy.
Invokamet XR will be available as 4 dosage strengths: 50mg/500mg, 50mg/1000mg, 150mg/500mg, and 150mg/1000mg in 60-count bottles.
For more information call (800) 526-7736 or visit Janssen.com.