Forxiga (dapagliflozin, DAPA) is indicated, either as mono- or adjunctive therapy, for adults (≥18 years) with type 2 diabetes to improve glycaemic control. The dosage is usually 10 mg once daily as oral therapy. Adjusted for placebo DAPA as mono- or adjunctive therapy gives a clinically relevant reduction in HbA1c of 0.66 %-point and 0.54-0.68 %-point respectively measured over 24 weeks. The most frequently occurring adverse events are hypoglycaemia (when used concomitantly to sulfonylureas and insulin) and genital infections. Post marketing studies are investigating a potential increased risk of breast-, bladder- and prostate tumors.
It is IRFs overall assessment that Forxiga, either as mono- or adjunctive therapy, should not be first line treatment of type 2 diabetes. In spite of a clinically relevant reduction in HbA1c compared to placebo, evidence for both monotherapy and adjunctive therapy compared to an active comparator still lacks. Furthermore treatment is substantially more expensive than other relevant alternatives and the safety profile has not yet been thoroughly described.
Forxiga was marketed December 10th 2012. It is subject to general reimbursement.