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The Committee's positive decision was based on Entersto's overall analysis of efficacy and safety.
includes phase III studies (PARAGON-HF) active control subgroup analysis results for HFpEF patients and Phase II studies (PARAMOUNT) results, as well as evidence of the efficacy of Phase III PARA (PARADIGM-HF) studies for HFrEF patients.
PARAGON-HF results show that Entresto has important clinical benefits for HFpEF patients and is safe, consistent with HFrEF's extensive clinical studies and post-market experience.
July 2017, Entresto was approved by NMPA to be listed in China for the treatment of patients with decreased shot blood fraction heart failure (HFrEF).
heart failure (HF) is a serious ongoing disease that affects about 26 million people worldwide, mainly in the HFpEF and HFrEF categories, both of which have the same number of patients.
, HFpEF is a special type of HF that causes the heart muscle to contract normally, but the chamber does not relax as it does when the chamber is full/relaxed.
HFpEF may be associated with high hospitalization, low quality of life and high mortality, and is becoming the main form of HF.
currently has no approved HFpEF therapy.
David Soergel, M.D., Global Head of Cardiovascular, Kidney and Metabolic Drug Development at Novart, said, "We are committed to fulfilling our commitment through a wide range of clinical research projects on heart failure.
encouraged by the latest feedback from the Committee.
we thank patients and patient organizations for their valuable advice on this serious disease and look forward to the FDA's decision on this new adaptation.
" According to the Pharmaceutical Rubik's Cube NextPharma database, Entresto's global sales in 2019 amounted to $1,726 million.
content Source: Medical Rubik's Cube Info