Europe's CHMP recommends AZ's Forxiga in type 1 diabetes

The European Medicines Agency’s CHMP regulatory committee has recommended AstraZeneca’s Forxiga to help adults with type 1 diabetes manage their blood sugar.

Forxiga (dapagliflozin) is already approved in Europe in patients with type 2 disease, but could become the first oral medicine approved as an adjunct to insulin in patient with type 1 disease.

The drug is a selective sodium glucose cotransporter-2 (SLGT2) class drug and is recommended in use with patients with BMI above 27 kg/m2 when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.

Regulators in the US and Japan are also reviewing Forxiga as an adjunct to insulin in adults with type 1 disease.

Also known as Farxiga in certain areas including the US, the drug has become a consistent performer for AstraZeneca following FDA approval in 2014 in type 2 disease.

Although the type 1 indication is a smaller market, AZ’s hopes the drug will be popular with patients who are struggling to control blood sugar with insulin alone, and will not require an additional injection.

Sales of the drug were $355 million in the last quarter, and it broke through the billion-dollar annual revenue barrier in full year 2017.

Elisabeth Björk, vice president, head of AZ’s cardiovascular, renal and metabolism BioPharmaceuticals division, said: “People with type-1 diabetes have not seen oral treatment innovation in decades and we believe today’s announcement signals an important advancement for them, as well as a broader understanding of the well-established clinical profile of Forxiga for people living with metabolic diseases.”

The positive opinion is based on phase 3 data from the DEPICT (Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1-Diabetes) clinical programme.

The 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.

The CHMP's decision will now be passed to the European Commission, which will likely grant an extension to its licence within the coming months.