Sector News

AZ’ Forxiga label updated in EU for type II diabetes

August 6, 2019
Life sciences

The European Commission has approved an update to the marketing authorisation for Forxiga (dapagliflozin) to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial, AstraZeneca has announced today.

The update applies to adults with type II diabetes, and was decided after the drug achieved a statistically-significant reduction in the composite endpoint of hospitalisation for heart failure or CV death versus placebo, one of the two primary efficacy endpoints in the trial.

The data also confirmed the well-established safety profile of the treatment, with no significant imbalance with Forxiga versus placebo in amputations, fractures, bladder cancer or Fournier’s gangrene.

The first-in-class, oral once-daily SGLT2 inhibitor is currently indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction, as an adjunct to diet and exercise.

Mene Pangalos, executive vice president, BioPharmaceuticals R&D, explained that for patients with the disorder, “heart failure is one of the earliest cardiovascular complications before heart attack or stroke. In the Phase III DECLARE-TIMI 58 trial, Forxiga reduced the composite endpoint of hospitalisation for heart failure or cardiovascular death in patients with type II diabetes, and we look forward to bringing these additional benefits of the medicine to people with type II diabetes in the EU.”

The news comes weeks after the drug was hit with a complete response letter by the US Food and Drug Administration (FDA), regarding a supplemental New Drug Application.

By: Anna Smith

Source: Pharma Times

comments closed

Related News

June 24, 2022

Echosens and Novo Nordisk announce partnership to increase awareness and advance early diagnosis of NASH

Life sciences

Echosens, a high-technology company offering liver diagnostic solutions, and Novo Nordisk A/S, a leading global healthcare company, announced a partnership to advance early diagnosis of non-alcoholic steatohepatitis (NASH) and increase awareness of the disease among patients, healthcare providers and other stakeholders.

June 24, 2022

argenx receives positive CHMP opinion for Efgartigimod for the treatment of adult patients with Generalized Myasthenia Gravis in Europe

Life sciences

Positive opinion based on Phase 3 ADAPT trial showing efgartigimod provided clinically meaningful improvements in strength and quality of life measures. If approved, efgartigimod will be the first neonatal Fc receptor (FcRn) blocker for the treatment of adults in Europe living with rare neuromuscular disease generalized myasthenia gravis (gMG).

June 24, 2022

Galapagos finally takes M&A plunge, spending $251M for 2 biotechs in CAR-T push

Life sciences

Galapagos CEO Paul Stoffels, M.D., has finally taken the plunge on M&A. The newly minted chief executive has signed not one but two deals in an attempt to right the ship, bringing two small biotechs aboard for a combined 239 million euros ($251.4 million).