FARXIGA Granted FDA Priority Review For Patients With Heart Failure With Reduced Ejection Fraction
January 06 2020 - 7:00AM
Business Wire
AstraZeneca today announced the US Food and Drug Administration
(FDA) has accepted a supplemental New Drug Application (sNDA) and
granted Priority Review for FARXIGA® (dapagliflozin) to reduce the
risk of cardiovascular (CV) death or the worsening of heart failure
(HF) in adults with heart failure with reduced ejection fraction
(HFrEF) with and without type 2 diabetes (T2D).
The Prescription Drug User Fee Act date, the FDA action date for
this supplemental application, is scheduled for the second quarter
of 2020.
The sNDA was based on results from the landmark Phase III
DAPA-HF trial published in September 2019 in The New England
Journal of Medicine, which showed FARXIGA on top of standard of
care reduced the incidence of the composite outcome of CV death or
the worsening of HF versus placebo. FARXIGA is not indicated to
reduce the risk of hospitalization for heart failure (hHF) in
patients without diabetes, or to reduce the risk of CV death.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: “FARXIGA is well established in the treatment of
type 2 diabetes and this Priority Review shows its potential to
also impact millions of patients with heart failure. If approved,
FARXIGA will be the first and only medicine of its kind indicated
to treat patients with heart failure.”
In September 2019, the FDA granted Fast Track designation for
the development of FARXIGA in HF. In August 2019, the FDA also
granted Fast Track designation for the development of FARXIGA to
delay the progression of renal failure and prevent CV and renal
death in patients with chronic kidney disease, with and without
T2D.
FARXIGA is indicated as an adjunct to diet and exercise to
improve glycemic control in adults with T2D. In October 2019, the
FDA also approved FARXIGA to reduce the risk of hospitalization for
heart failure in patients with T2D and established cardiovascular
disease or multiple CV risk factors.
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.
Please see accompanying US Full Prescribing Information and
Medication Guide for FARXIGA.
NOTES TO EDITORS
About DAPA-HF
DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in
Heart Failure) is an international, multicenter, parallel group,
randomized, double-blind 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 outcome was time to a worsening heart failure
event (hospitalization or equivalent event; i.e. an urgent heart
failure visit), or cardiovascular death.
The full results of the DAPA-HF trial were published in The New
England Journal of Medicine in September 2019.
About heart failure
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 which
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 ‘malignant’ 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.
About 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.
About 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.
US-35445 Last Updated 1/20
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200106005339/en/
Media Inquiries Michele Meixell +1 302 885 2677
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Mar 2024 to Apr 2024
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Apr 2023 to Apr 2024