First Oral Medication to Treat T1D Approved in Europe
The European Commission (EC) has approved the use of Forxiga (dapagliflozin) as an add-on treatment to insulin therapy for use in patients with type 1 diabetes (T1D) who have a BMI ≥ 27 kg/m2. AstraZeneca announced the news in a press release today, with a representative stating, “We look forward to bringing Forxiga to a patient population that has not had any approved oral medicines available before.”
Forxiga (Farxiga in the U.S.) is an SGLT-2 inhibitor, which works by reducing the reabsorption of glucose by the kidneys, and increasing glucose excretion in urine. Other recognizable name brand drugs in this class include Invokana and Jardiance. SGLT-2 inhibitors have been approved for treatment of type 2 diabetes for several years, and have been used off-label by people with type 1 diabetes for just as long.
Trial results for Forxiga showed significant reductions in HbA1c levels, weight loss and lower daily insulin requirements. The risk of diabetic ketoacidosis (DKA) was noted to be substantially higher among participants, which is likely a reason for the limited approval for use only in certain patients. The announcement specifies approval for patients with a BMI over 27 who are also not meeting blood sugar goals on intensive insulin therapy alone.
The news comes on the heels of the FDA declining to approve Zynquista (sotagliflozin)—an SGLT-1/2 dual inhibitor—for treatment of T1D in the United States last week. Zynquista is likely to be approved in Europe however, as the preliminary recommendations from the Committee for Medicinal Products for Human Use (CHMP) were considerably more positive than the recommendations from the FDA Advisory Committee in the U. S.
Forxiga is currently under review in Japan and the United States for use in T1D in conjunction with insulin therapy, and AstraZeneca expects decisions on the drug in the first and second half of 2019 respectively.
Update 3/28/2019: Forxiga has been approved for use in T1D in Japan.
To learn more about SGLT Inhibitors for use in Type 1 diabetes, click here.