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AZ's Farxiga becomes first FDA-approved SGLT2 inhibitor for heart failure with reduced ejection fraction

The FDA has moved to approve an oral tablet formulation of AstraZeneca’s Farxiga (dapagliflozin) to reduce the risk of cardiovascular death and hospitalisation in adult patients with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction.

The decision makes the drug the first  sodium-glucose co-transporter 2 (SGLT2) inhibitor available in the US in this indication.

FDA gives a priority review for key heart failure drug Farxiga

The FDA has accepted a New Drug Application (sNDA) and has granted a priority review for AstraZeneca's drug Farxiga (dapagliflozin) to reduce the risk of heart failure (HF) and cardiovascular death.

This sNDA and the priority review is based on results from Phase III trials published in The New England Journal of Medicine back in September 2019. This shows that Farxiga is reduced the incidence of the composite outcome of CV death or the worsening of HF versus placebo.

AstraZeneca's Farxiga meets Phase 3 primary endpoint in heart failure

New Phase 3 data has been unveiled for AstraZeneca’s Farxiga (dapagliflozin), confirming that the SGLT2 inhibitor met its primary composite endpoint when added to standard of care by achieving 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.

The data was derived from a study comprised of patients with reduced ejection fraction (HFrEF) when given standard of care treatment, including those with and without type-2 diabetes.

AstraZeneca's Farxiga fails to get FDA approval for patients with Type 1 diabetes

The FDA had said it will not approve AstraZeneca’s diabetes drug Farxiga for use as a supplement to insulin in adults with Type 1 diabetes who haven’t been able to control their condition with insulin alone.

Farxiga is currently approved in the United States for adults with Type 2 diabetes, the more common form of the condition.

The US regulator has however declined to approve the drug for use in patients with Type 1 diabetes. AstraZeneca did not say what specific concerns had been raised by the FDA.

AstraZeneca's Phase 3 Farxiga data impresses in type 2 diabetes

AstraZeneca has presented new Phase 3 data at the American Diabetes Association (ADA) 79th Scientific Sessions in San Francisco on its sodium-glucose co-transporter 2 (SGLT2) inhibitor Farxiga (dapagliflozin), demonstrating that the drug successfully reduced the progression of kidney disease or renal death in patients with type 2 diabetes (T2D).

Derived from 17,160 T2D patients with predominantly reserved renal function irrespective of underlying atherosclerotic CV disease (ASCVD), the data revealed that Farxiga reduced the relative risk of the composite renal-specific outcome of k

AZ's Farxiga reduces major adverse cardiovascular event risk in type 2 diabetes, new data shows

AstraZeneca has lifted the curtain on new Phase 3 data for its sodium-glucose co-transporter 2 (SGLT2) inhibitor Farxiga (dapagliflozin), reinforcing the drug’s efficacy in reducing the relative risk of major adverse cardiovascular events (MACE) in patients with type-2 diabetes (T2D) who had a prior heart attack.

Findings from a pre-specified sub-analysis indicated that the therapy reduced the risk of MACE by 16% compared to placebo, and also reduced the relative risk of hospitalisation for heart failure (hHF) in T2D patients regardless of their ejection fraction (EF) stat

AZ's Farxiga shows strength in largest ever SGLT2 inhibitor cardiovascular outcomes study

AstraZeneca has revealed new data for its sodium-glucose co-transporter 2 (SGLT2) inhibitor Farxiga (dapagliflozin) at the American Heart Association (AHA) Scientific Sessions 2018 in Chicago, showing that the drug “significantly reduced” hospitalisation or death arising from cardiovascular (CV) conditions in a broad patient population.

The findings were derived from the DECLARE trial, the largest SGLT2 inhibitor CV outcomes study ever conducted, encompassing more than 17,000 participants.

AstraZeneca's Farxiga cuts heart risk in type 2 diabetes patients

AstraZeneca has unveiled new Phase 3 data for its SGLT2 inhibitor Farxiga (dapagliflozin), showing with the drug demonstrating positive findings in the in improving cardiovascular (CV) outcomes vs placebo in patients with type 2 diabetes (T2B) and multiple CV risk factors or established disease.

In the large-scale trial, which was conducted across 33 different countries over five years and involved over 17,000 participants, Farxiga was shown to achieve a “statistically significant reduction” in hospitalisations for heart failure (hHF) or CV death

AstraZeneca’s Forxiga displays potential in type 1 diabetes

Forxiga is AstraZeneca’s treatment for those living with type 2 diabetes but the results from a new trial have found that the pill may have benefits in harder to treat type 1 diabetes.

The study found that adding the treatment to insulin therapy in those living with type 1 diabetes allowed those receiving the pill to better manage their blood sugar levels. There was a reported additional benefit of weight loss and requiring fewer insulin doses. On average, glucose levels remained at a healthy level for at least two hours longer on average between doses.

FDA issues warnings on Janssen, AstraZeneca diabetes drugs

The US Food and Drug Administration has issued a warning of the risk of acute kidney injury for the type-2 diabetes medicines Invokana (canagliflozin) and Farxiga (dapagliflozin), made by Janssen and AstraZeneca respectively.

This latest warning strengthens the existing guidance on these drugs. Invokana and Farxiga belong to a class of drugs called sodium-glucose cotransporter-2 (SGLT-2) inhibitors which, by lowering blood sugar, can cause the kidneys to remove sugar through the body through urine.

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