Benzinga | Dec 10, 2021 12:46PM EST

AstraZeneca's Dapagliflozin No Longer Authorized For Type 1 Diabetes In UK

On 25 October 2021, the marketing authorization holder for dapagliflozin withdrew the indication for type 1 diabetes across Europe and the U.K. The SGLT2 inhibitor dapagliflozin has been indicated for the treatment of type 2 diabetes since 2012.

* AstraZeneca Plc's (NASDAQ:AZN) dapagliflozin 5mg (Forxiga/Farxiga) was authorized in 2019 as an adjunct to insulin in patients with type 1 diabetes with a body-mass index (BMI) of 27 kg per m2.

* The decision to voluntarily withdraw the indication in type 1 diabetes followed commercial considerations due to a specific European-wide regulatory requirement for this authorization.

* The decision was not driven by any new safety concerns.

* Other indications for dapagliflozin 5mg and 10mg are not affected by this change, and both strengths will remain on the market.

* Dapagliflozin remains authorized in adults for type 2 diabetes, symptomatic chronic heart failure with reduced ejection fraction, and chronic kidney disease.

* Price Action: AZN shares are down 1.68% at $54.04 during the market session on the last check Friday.