Therapy Areas: Cardiovascular
AstraZeneca's Forxiga receives positive opinion from EU CHMP
4 February 2019 -

AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a new indication for the marketing authorisation of Forxiga (dapagliflozin), after adopting a positive opinion for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).

Forxiga, a selective sodium glucose cotransporter-2 (SGLT2) inhibitor, is the first oral medicine to receive a positive recommendation from the EMA for use in T1D as an adjunct to insulin in patients with BMI = 27 kg/m2 (kilogram per square metres), when insulin alone does not provide adequate glycaemic control, despite optimal insulin therapy.

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

According to the company, 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.

Also, Forxiga is under regulatory review in the US and Japan for use as adjunct treatment to insulin in adults with T1D.

AstraZeneca focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.

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