FARXIGA reduced the incidence of heart failure worsening or cardiovascular death in a sub-analysis from landmark Phase III DA...
March 28 2020 - 09:53AM
Business Wire
New data showed consistent effect of FARXIGA
in patients with heart failure with reduced ejection fraction,
regardless of background therapy
New data from a sub-analysis of the landmark Phase III DAPA-HF
(Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure)
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 (i.e. other medications
for heart failure).
FARXIGA was evaluated in patients who were receiving a broad
range of pharmacological treatments, device therapies and cardiac
resynchronization therapy for HFrEF. A consistent reduction in the
primary outcome was observed across all these treatment
subgroups.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: “These new data from the DAPA-HF trial further
reinforce FARXIGA’s clinical effects beyond diabetes. By reducing
the risk of heart failure worsening regardless of background
therapy, FARXIGA has the potential to improve current standard of
care and reduce the burden of disease for heart failure patients
across the globe.”
The results were made available at the American College of
Cardiology’s 69th Annual Scientific Session Together with World
Congress of Cardiology (ACC.20/WCC) and were published in the
European Heart Journal.
FARXIGA is indicated as an adjunct to diet and exercise to
improve glycemic control in adults with T2D. In the US it is also
approved to reduce the risk of hospitalization for HF in patients
with T2D and established CV disease or multiple CV risk
factors.
In January 2020, the US Food and Drug Administration (FDA)
accepted a supplemental New Drug Application (sNDA) and granted
Priority Review for FARXIGA to reduce the risk of CV death or the
worsening of HF in adults with HFrEF with and without T2D. The
Prescription Drug User Fee Act date, the FDA action date for this
supplemental application, is scheduled for the second quarter of
2020.
Indication and Limitations of Use for FARXIGA®
(dapagliflozin) tablets
FARXIGA is indicated:
- as an adjunct to diet and exercise to improve glycemic control
in adults with type 2 diabetes mellitus
- to reduce the risk of hospitalization for heart failure in
adults with type 2 diabetes mellitus and established cardiovascular
disease or multiple cardiovascular risk factors
FARXIGA is not recommended for patients with type 1 diabetes
mellitus or for the treatment of diabetic ketoacidosis.
Important Safety Information for FARXIGA® (dapagliflozin)
tablets
Contraindications
- Prior serious hypersensitivity reaction to FARXIGA
- Severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage
renal disease, or patients on dialysis
Warnings and Precautions
- Hypotension: FARXIGA causes intravascular volume
contraction, and symptomatic hypotension can occur. Assess and
correct volume status before initiating FARXIGA in patients with
impaired renal function, elderly patients, or patients on loop
diuretics. Monitor for hypotension
- Ketoacidosis has been reported in patients with type 1
and type 2 diabetes receiving FARXIGA. Some cases were fatal.
Assess patients who present with signs and symptoms of metabolic
acidosis for ketoacidosis, regardless of blood glucose level. If
suspected, discontinue FARXIGA, evaluate and treat promptly. Before
initiating FARXIGA, consider risk factors for ketoacidosis.
Patients on FARXIGA may require monitoring and temporary
discontinuation in situations known to predispose to
ketoacidosis
- Acute Kidney Injury: FARXIGA causes intravascular volume
contraction and can cause acute kidney injury. Reports of acute
kidney injury requiring hospitalization and dialysis have occurred
with FARXIGA. If acute kidney injury occurs, discontinue and
promptly treat Increases in serum creatinine and decreases in eGFR
may be observed with initiation of FARXIGA. Elderly patients and
patients with impaired renal function may be more susceptible to
these changes. Consider temporarily discontinuing in settings of
reduced oral intake or fluid losses Before initiating FARXIGA,
evaluate renal function and monitor periodically. FARXIGA is not
recommended when the eGFR is <45 mL/min/1.73 m2
- Urosepsis and Pyelonephritis: SGLT2 inhibitors increase
the risk for urinary tract infections [UTIs] and serious UTIs have
been reported with FARXIGA. Evaluate for signs and symptoms of UTIs
and treat promptly
- Hypoglycemia: FARXIGA can increase the risk of
hypoglycemia when coadministered with insulin and insulin
secretagogues. Consider lowering the dose of these agents when
coadministered with FARXIGA
- Necrotizing Fasciitis of the Perineum (Fournier’s
Gangrene): Rare but serious, life-threatening cases have been
reported in patients receiving SGLT2 inhibitors including FARXIGA.
Cases have been reported in females and males. Serious outcomes
have included hospitalization, surgeries, and death. Assess
patients presenting with pain or tenderness, erythema, swelling in
the genital or perineal area, along with fever or malaise. If
suspected, institute prompt treatment and discontinue FARXIGA
- Genital Mycotic Infections: FARXIGA increases the risk
of genital mycotic infections, particularly in patients with prior
genital mycotic infections. Monitor and treat appropriately
Adverse Reactions
In a pool of 12 placebo-controlled studies, the most common
adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and
placebo respectively were female genital mycotic infections (8.4%
vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and
urinary tract infections (5.7% vs 4.3% vs 3.7%).
Use in Specific Populations
- Pregnancy: Advise females of potential risk to a fetus
especially during the second and third trimesters.
- Lactation: FARXIGA is not recommended when
breastfeeding.
Dosing
- To improve glycemic control in patients with T2D, the
recommended starting dose of FARXIGA is 5 mg once daily, taken in
the morning. In patients tolerating FARXIGA 5 mg once daily who
require additional glycemic control, the dose can be increased to
10 mg once daily.
- To reduce the risk of hospitalization for heart failure in
patients with T2D, the recommended dose of FARXIGA is 10 mg once
daily.
Please see accompanying US Full Prescribing Information and
Medication Guide for FARXIGA.
Notes
Heart failure
HF is a life-threatening disease in which the heart cannot pump
enough blood around the body. It affects approximately 64 million
people worldwide, at least half of whom have a reduced ejection
fraction, and is a chronic and degenerative disease where half of
patients will die within five years of diagnosis. HF remains as
fatal as some of the most common cancers in both men (prostate and
bladder cancers) and women (breast cancers). It is the leading
cause of hospitalization for those over the age of 65 and
represents a significant clinical and economic burden.
DAPA-HF
DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in
Heart Failure) is an international, multicenter, parallel-group,
randomized, double-blinded trial in patients with heart failure and
reduced ejection fraction (LVEF ≤ 40%), with and without T2D,
designed to evaluate the effect of FARXIGA 10mg, compared with
placebo, given once daily in addition to standard of care. The
primary composite endpoint was time to the first occurrence of a
worsening heart failure event (hospitalization or equivalent event;
i.e. an urgent heart failure visit), or cardiovascular death.
AstraZeneca in CV, Renal & Metabolism (CVMD)
CV, renal and metabolism together form one of AstraZeneca’s main
therapy areas and a key growth driver for the Company. By following
the science to understand more clearly the underlying links between
the heart, kidneys and pancreas, AstraZeneca is investing in a
portfolio of medicines to protect organs and improve outcomes by
slowing disease progression, reducing risks and tackling
co-morbidities. Our ambition is to modify or halt the natural
course of CVMD diseases and potentially regenerate organs and
restore function, by continuing to deliver transformative science
that improves treatment practices and CV health for millions of
patients worldwide.
AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal &
Metabolism and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. For more information, please visit
www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.
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