-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
On Tuesday, Novarma Pharmaceuticals announced that the FDA had approved Enteresto's expansion for blood fraction retention heart failure (HFpEE) patients.
with the approval of the extended label, Entresto became the first and only treatment approved for both heart failure disorders (HFrEF and HFpEF).
July 2015, Entresto was first approved by the FDA for the treatment of patients with reduced shot blood fractions (HFrEF), and Entresto was approved for listing in China in 2017.
December, Novaral announced that the FDA's Advisory Committee on Cardiovascular and Kidney Medicines (CRDAC) had voted 12 to 1 in support of the use of Entersto to treat HFpEF.
Entresto is a cocrystalline complex of sodium salts combined with sakubaquon and psalone, a bi-acting angiotensin-subjectase inhibitor (ARNI), with a unique mode of action that enhances the heart's protective neuroendocrine system and is thought to reduce the strain of a failed heart.
the Approval of Entersto, mainly based on evidence of efficacy and safety obtained in the PARAGON-HF trial.
PARAGON-HF trial was a randomized, double-blind, active drug-controlled trial that recruited a total of 4,822 patients with cardiac failure (HF) of structural heart disease with a grade II.-IV., a blood test score ≥45 percent, elevated sodium peptides, and structural heart disease.
PARAGON-HF trial results showed that Entresto had important clinical benefits for HFpEF patients in specific subgroups, with the drug benefiting most especially in patients with lower-than-normal blood test scores.
since its launch, Entresto has been increasingly well-positioned to benefit clinically from chronic heart failure and has been approved as the new standard treatment for heart failure patients in more than 100 countries around the world, but sales are still progressing at a slower pace than expected.
the approval, the drug's range of adaptations is expected to accelerate sales growth.
Jefferies analyst Peter Welford said in a note to clients last year that HFpEF adaptation could add about $1 billion to Entersto's top sales revenue, which will peak at $6.1 billion.
sales rose 35 percent year-on-year to $716 million in the fourth quarter, 4 percent higher than expected, according to Novartra's fourth-quarter 2020 results.
2020, Entresto's full-year global sales reached $2,497 million, up 45% from 2019.
now, Entresto is Novardo's third-largest source of revenue.
source: 1. Novartis Entresto® granted expanded indication in chronic heart failure by FDA2. Novartis' blockbuster heart med Entresto snags FDA approval in larger patient group