Marketing variation for Forxiga accepted by EMA

AstraZeneca (LSE: AZN) today announced that the European Medicines Agency has accepted the Marketing Authorization Variation for Forxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).

The submission acceptance is based on Phase III data from the DEPICT (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes) 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, when given as an oral adjunct to adjustable insulin in patients with inadequately-controlled T1D, demonstrated significant and clinically-relevant reductions from baseline in HbA1c, weight and total daily insulin dose at 24 and 52 weeks, compared to placebo, at both 5mg and 10mg doses.

Forxiga, which in 2017 generated revenues of $1.1 billion for Anglo-Swedish pharma major AstraZeneca, was first approved in the European Union in November 2012 and in the USA in January 2014. The drug, which is also marketed under the Farxiga trade name, was developed in partnership with US pharma major Bristol-Myers Squibb (NYSE: BMY).