AZ's diabetes drug Forxiga approved in EU for type 1 disease
AstraZeneca’s diabetes drug Forxiga (dapagliflozin) has been approved in the EU in patients with type 1 disease.
Forxiga has been approved as an adjunct to insulin in patients with a BMI greater than 27kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal therapy.
This is the first approval of Forxiga, branded as Farxiga in the US, for type 1 diabetes (T1D).
Regulators in the US and Japan are reviewing the drug as an adjunct to insulin in patients with T1D and decisions are expected in the first and second half of this year, respectively.
Approval is based on data from the phase 3 DEPICT clinical programme for Forxiga in T1D.
The short-term (24 week) and long-term (52 week) data from DEPICT-1, along with the short-term data from DEPICT-2, showed that Forxiga 5mg daily, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled T1D, demonstrated significant and clinically-meaningful reductions from baseline in average blood glucose levels HbA1c (primary endpoint), weight and total daily insulin dose (secondary endpoints) at 24 and 52 weeks.
The safety profile of Forxiga in these T1D trials was consistent with its profile in type-2 diabetes (T2D), with the exception of a higher number of diabetic ketoacidosis (DKA) events in Forxiga-treated patients.
DKA is a known complication for adults with T1D that affects those with T1D more frequently than with T2D.
Forxiga is already indicated as a monotherapy and as part of combination therapy in adults with T2D to improve glycaemic control, with the additional benefits of weight loss and blood pressure reduction, as an adjunct to diet and exercise.
Farxiga is AZ’s fifth biggest selling drug, making up around 7% of product sales.
Last year’s sales of nearly $1.4 billion were a 30% year-on-year increase, but its main US patent is set to expire next year, and its EU patent in 2023.
So AZ is trying to make the most of the drug it acquired from Bristol-Myers Squibb after buying out the latter’s share in a diabetes partnership struck at the beginning of the decade.