CHMP recommends Forxiga to treat type 1 diabetes. -Astra Zeneca

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a new indication for the marketing authorisation of Forxiga (dapagliflozin), from AstraZeneca, after adopting a positive opinion for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).

Forxiga, a selective sodium glucose cotransporter-2 (SGLT2) inhibitor, is the first oral medicine to receive a positive recommendation from the EMA for use in T1D as an adjunct to insulin in patients with BMI greater than 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy. The positive opinion is based on Phase III data from the DEPICT (Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1-Diabetes) clinical programme.The DEPICT clinical programme consists of two trials, DEPICT-1 and -2, with the primary efficacy endpoint at 24 weeks and a long-term extension up to 52 weeks. Both trials demonstrated that Forxiga, when given as an oral adjunct to adjustable insulin in adults with inadequately-controlled T1D, showed significant reductions from baseline in HbA1c (primary endpoint), weight and total daily insulin dose (secondary endpoints) at 24 and 52 weeks, vs. placebo, at both 5mg and 10mg doses.