Drugs / sacubitril/valsartan
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | congestive heart failure | 2020-03-02 | “Novartis Pharma is currently applying for approval of the drug in Japan with a planned indication for chronic heart failure.” otsuka.co.jp ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT01870739 | Oct 2013 → Jun 2015 | hypertensive disorder | Novartis Pharmaceuticals | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2021-02-16 | Novartis Pharmaceuticals | Regulatory Novartis Entresto® granted expanded indication in chronic heart failure by FDA novartis.com ↗
Novartis today announced that the US Food and Drug Administration (FDA) has approved the following expanded indication for Entresto ® (sacubitril/valsartan): to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure |
| 2019-11-17 | Novartis Pharmaceuticals | Results Novartis PARAGON-HF analyses suggest Entresto® benefit beyond HFrEF novartis.com ↗
The data suggest that, in specific subgroups, treatment with Entresto may result in greater reductions in heart failure hospitalizations and cardiovascular death, as compared to valsartan. |
| 2018-08-25 | Novartis Pharmaceuticals | Results Novartis announces new data that show Entresto® (sacubitril/valsartan) can be initiated early & safely in hospitalized patients after an acute heart failure episode novartis.com ↗
TRANSITION shows that Entresto can be safely initiated shortly after an acute heart failure episode, both in the hospital and in an out-patient setting and in a wide range of stabilized patients[1] |
| 2017-11-12 | Novartis Pharmaceuticals | Results New Novartis Entresto® real world evidence data shows beneficial impact on quality of life in people living with heart failure novartis.com ↗
Entresto significantly reduced levels of NT-proBNP, a key blood marker associated with cardiovascular risk in patients with heart failure; the magnitude of the decrease was similar to that observed in the PARADIGM-HF study[1] |
| 2016-06-22 | Novartis Pharmaceuticals | Results Timely use of Novartis' Entresto could prevent or postpone over 28,000 US deaths per year among HFrEF patients, according to an expert analysis in JAMA Cardiology novartis.com ↗ |
| 2016-04-02 | Novartis Pharmaceuticals | Results New analyses show Novartis' Entresto(TM) reduced cardiovascular death or hospitalization for heart failure, consistently benefitting patients with reduced ejection fraction regardless... novartis.com ↗
In a second analysis, patients taking Entresto had about a 20% reduction in CV death or heart failure hospitalization compared to those taking enalapril, regardless of background therapy[1],[2] |
| 2015-10-27 | The Medicines Company | Results Novartis a réalisé, au troisième trimestre, une forte hausse de sa marge core (tcc) et continué de renforcer son pipeline, confirmant ainsi ses prévisions pour l'exercice novartis.com ↗
De nouvelles données sur Cosentyx ont montré une efficacité durable chez les malades atteints de psoriasis après trois ans de traitement |
All press releases naming this drug 10 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sacubitril/valsartan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01870739 ↗ |
| Known as | LCZ696 | “sacubitril/valsartan (LCZ696)” NCT01870739 ↗ |