Kategorier: diabetes

5 September 2022 08:06

Forxiga approved in China for the treatment of chronic kidney disease in patients at risk of progression with and without type-2 diabetes

AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in China to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death and hospitalisation for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression with and without type-2 diabetes (T2D).

11 Juni 2020 08:01

AstraZeneca to showcase leadership in treating type-2 diabetes and cardiorenal complications at ADA 2020

AstraZeneca will present new data from the landmark Phase III DAPA-HF and DECLARE-TIMI 58 trials at the upcoming 80th American Diabetes Association (ADA) Virtual Scientific Sessions, 12-16 June 2020. The data are among 23 accepted abstracts.....

28 Mars 2020 14:20

Farxiga reduced the incidence of heart failure worsening or cardiovascular death in a sub-analysis from landmark Phase III DAPA-HF trial

New data from a sub-analysis of the landmark Phase III DAPA-HF trial showed that AstraZeneca’s Farxiga (dapagliflozin) reduced the incidence of the primary composite endpoint of heart failure (HF) worsening or cardiovascular (CV) death compared to placebo, in patients with heart failure with reduced ejection fraction (HFrEF), irrespective of their background therapy.

15 November 2019 08:02

Qtrilmet approved in the EU for the treatment of type-2 diabetes

​AstraZeneca today announced that the European Commission (EC) has approved Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycaemic control in adults with type-2 diabetes (T2D).

7 November 2019 22:41

Roxadustat significantly increased haemoglobin levels for chronic kidney disease patients with anaemia in Phase III OLYMPUS and ROCKIES trials

AstraZeneca today presented detailed results from the Phase III OLYMPUS and ROCKIES trials showing that roxadustat significantly increased haemoglobin (Hb) levels in non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients with anaemia from chronic kidney disease (CKD), respectively.

21 Oktober 2019 08:02

Farxiga approved in the US to reduce the risk of hospitalisation for heart failure in patients with type-2 diabetes

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in adults with type-2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.

4 Oktober 2019 08:02

Fasenra approved in the US for self-administration in a new pre-filled auto-injector, the Fasenra Pen

​AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved the self-administration of Fasenra (benralizumab) in a pre-filled, single-use auto-injector (the Fasenra Pen).

23 September 2019 08:02

Qtrilmet recommended for approval in EU by CHMP for the treatment of type-2 diabetes

​AstraZeneca today announced that Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets have been recommended for marketing authorisation in the European Union for the treatment of adults with type-2 diabetes (T2D).

16 September 2019 08:09

FDA grants Fast Track designation for Farxiga in heart failure

​AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death, or the worsening of heart failure, in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).

1 September 2019 14:33

Detailed results from Phase III DAPA-HF trial showed Farxiga significantly reduced both the incidence of cardiovascular death and the worsening of heart failure

AstraZeneca today announced detailed results from the landmark Phase III DAPA-HF trial that showed Farxiga (dapagliflozin) on top of standard of care reduced both the incidence of cardiovascular death and the worsening of heart failure.

20 Augusti 2019 08:02

Farxiga met primary endpoint in landmark Phase III DAPA-HF trial for the treatment of patients with heart failure

AstraZeneca today announced positive results from the landmark Phase III DAPA-HF trial which showed that Farxiga(dapagliflozin) met theprimary composite endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure (defined as hospitalisation or an urgent heart failure visit), compared to placebo.

5 Augusti 2019 08:04

Forxiga label updated in the EU in type-2 diabetes

AstraZeneca today announced that 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 in adults with type-2 diabetes (T2D). The trial enrolled a majority of patients with no existing cardiovascular disease.

15 Juli 2019 08:14

Update on US regulatory decision for Farxiga in type-1 diabetes

AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the supplemental New Drug Application for Farxiga (dapagliflozin) as an adjunct treatment to insulin to improve glycaemic control in adult patients with type-1 diabetes (T1D), when insulin alone does not provide adequate glycaemic control.

1 Juli 2019 08:07

Forxiga receives positive EU CHMP opinion for DECLARE-TIMI 58 cardiovascular outcomes data

AstraZeneca today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a change to the European marketing authorisation for Forxiga (dapagliflozin) in patients with type-2 diabetes (T2D) to include cardiovascular (CV) outcomes data from the Phase III DECLARE-TIMI 58 trial.

10 Juni 2019 08:11

Njur- och hjärtsvikt är de vanligaste första kardiovaskulära komplikationerna vid typ 2-diabetes

Första resultat från observationsstudien CaReMe, baserad på registerdata från bland annat Sverige under åren 2007 till 2016, presenterades vid den amerikanska diabeteskongressen, ADA, den 9 juni. Studien har följt 645 180 personer med typ 2-diabetes som inte tidigare haft etablerad hjärt-kärlsjukdom.

1 Februari 2019 14:19

Forxiga receives positive EU CHMP opinion for the treatment of adults with type-1 diabetes

Forxiga is the first oral medicine recommended for approval in Europe
as an adjunct treatment to insulin for adults with type-1 diabetes
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 treat

12 November 2018 09:15

Fas III-studien DECLARE-TIMI 58 visar att dapagliflozin (Forxiga) som behandling av typ 2-diabetes i en bred patientpopulation signifikant minskar risken för sjukhusinläggning på grund av hjärtsvikt eller hjärtrelaterad död

Behandling av typ 2-diabetes med dapagliflozin (Forxiga) i en bred patientpopulation, minskar risken för sjukhusinläggningar på grund av hjärtsvikt eller hjärtrelaterad död med 17 procent jämfört med placebo (4,9% jämfört med 5,8%). Samtidigt bekräftas den sedan tidigare kända säkerhetsprofilen för dapagliflozin. Det visar de första resultaten från en stor internationell kardiovaskulär fas III-stu

29 Juni 2018 16:09

Bydureon receives positive EU CHMP opinion for new BCise device for patients with type-2 diabetes

AstraZeneca today announced that the CHMP of the European Medicines Agency (EMA) has adopted a positive opinion, recommending inclusion of Bydureon (2mg prolonged-release suspension for injection) BCise device as a new formulation within the marketing authorisation for Bydureon (exenatide extended-release) for the treatment of type-2 diabetes.

23 Oktober 2017 08:06

US FDA approves new easy-to-use, once-weekly Bydureon BCise injectable medicine for patients with type-2 diabetes

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise

16 Augusti 2017 09:00

Nordiska registerdata visar att SGLT-2-hämmare, jämfört med andra glukossänkande läkemedel, förknippas med en minskad risk för prematur hjärt-kärlsjukdom och död

Resultat publicerade i The Lancet Diabetes & Endocrinology från observationsstudien CVD-REAL Nordic, baserad på svenska registerdata, indikerar att behandling av typ 2-diabetes med SGLT-2-hämmare i klinisk praxis är associerad med minskad risk för kardiovaskulära insjuknanden, särskilt med dödlig utgång, jämfört med andra glukossänkande läkemedel, även hos patienter utan känd hjärt-kärlsjukdom.