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

Join the discussion!

Your email address will not be published. Required fields are marked *

Related News

January 17, 2021

SII expects WHO emergency approval of Covid-19 vaccine soon

Life sciences

The Serum Institute of India (SII) expects to soon receive World Health Organisation (WHO) emergency use authorisation for the Oxford University/AstraZeneca Covid-19 vaccine, produced for mid and low-income countries.

January 17, 2021

Sanofi to acquire clinical-stage biopharma firm Kymab for $1.45bn

Life sciences

According to the deal, Sanofi will gain full global rights to Kymab’s fully human monoclonal antibody, KY1005 that attaches to OX40-Ligand and can potentially treat various immune-mediated diseases and inflammatory ailments.

January 17, 2021

Moderna poaches Amgen vet as CCO, jump-starting commercial team as it rolls out COVID-19 vaccine

Life sciences

Moderna tapped veteran Amgen executive Corinne Le Goff to spearhead that effort as chief commercial officer.

Send this to a friend