A huge milestone that makes Forxiga the first add-on drug for people with type 1 diabetes in Europe
with special restrictions on indications and special written informations to health provider as well as for the patients
The European Medicines Agency (EMA) has approved the first “adjunct” (added to insulin) pill for people with type 1 diabetes in Europe with a body mass index (BMI) over 27. Called Forxiga, the once-daily pill lowers blood glucose, reduces the amount of insulin needed, and has been shown to cause 5-7 lbs of weight loss.
Forxiga is from a class of drugs called “SGLT-2 inhibitors” that cause the kidneys to excrete excess glucose through the urine, simultaneously lowering blood glucose and removing calories. SGLT-2 inhibitors are currently only approved in the US for people with type 2 diabetes.
The EMA’s decision to approve Forxiga was based on data from the DEPICT drug trials. DEPICT 1 showed that type 1 participants on Forxiga:
- Reduced A1C by 4-6 mmol/mol from an average starting A1C of 65 mol/mol;
- Increased time-in-range (4-10 mol/l P-Glukos) by about 2-3 hours per day, increasing from an average of 10.5 hours to about 13 hours;
- Lost about 3-4 kg from an average starting weight of about 80 kg, compared with no weight reduction for those taking a placebo (a “nothing” pill); and
- Decreased their total daily insulin dose by 9-13%, or about five to eight fewer units insulin per day.
The main safety concern for people with type 1 using SGLT inhibitors is diabetic ketoacidosis (DKA).
Over the 52-week study, 4% of participants on Forxiga and 1.1% on placebo experienced DKA. However, for people with a BMI of 27 or more, only 1.7% of the participants on Forxiga and 1.0% of those on placebo experienced DKA. See our infographic on strategies to reduce risk for DKA here – expanded patient education will be very important to reducing DKA rates. We are optimistic that the field can work collaboratively to make sure that healthcare providers and patients are as smart as possible about this safety concern.
Notably, this approval follows the recommendation from an EMA committee to approve Forxiga for adults with type 1 diabetes with a BMI of 27 or greater. The EMA committee also recommended approval of Zynquista (an SGLT-1/2 dual inhibitor sotagliflozin) for the same population of people with type 1. The EMA has not yet made an official decision on Zynquista, though typically it follows the recommendation of the committee.
In the US, Farxiga is currently under review by the FDA. In Japan, Forxiga was also recently approved for adults with type 1 diabetes regardless of BMI. The FDA recently decided not to approve Zynquista for people with type 1 diabetes. With the approval of Forxiga in the EU and likely approval of Zynquista, people with type 1 will soon have more treatment options beyond insulin.