About the DAPA-HF Trial
DAPA-HF is the first heart failure outcomes trial with an SGLT2 inhibitor investigating the treatment of heart failure with reduced ejection fraction (HFrFF) on top of standard of care, which includes: angiotensin converting enzymes (ACE) inhibitors, angiotensin II receptor blockers, beta blockers, mineralocorticoid-receptor antagonists and neprilysin inhibitors, in patients with or without Type 2 diabetes.
Prohost Observations
This news is great. Heart failure is a life-threatening disease in which the heart is unable to pump sufficient blood to the body’s organs. Around 65 million people suffer from heart failure worldwide; half of them are expected to die within 5 years of diagnosis.
Heart failure is the leading cause of hospitalization for people over 65 years old.
AstraZeneca’s news is, indeed, great.
However, the stock is still in the oversold territory.
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Vertex Has Good News for VX-445 Combination Regimen
Vertex (VRTX) has good news too; many pointing to promising future breakthroughs. From the most recent news, which was announced yesterday, we learned that the Food and Drug Administration (FDA) accepted Vertex’s New Drug Application (NDA) for the VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen.
In addition, the FDA has granted Priority Review of the NDA and assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 19, 2020.
The submission was supported by two global Phase 3 studies in people with cystic fibrosis; a 24-week Phase 3 study in people with two F508del mutations.
Both studies demonstrated statistically significant improvements in lung function (percent predicted forced expiratory volume in one second (ppFEV1) which was the primary endpoint, and all secondary endpoints.
The triple combination was well tolerated.
Prohost Observations
After learning details about the trial results, we tend to believe what Vertex’s Executive Vice President’s, Reshma Kewalrami MD., statement that, if approved, the triple combination regimen would be a significant advancement in cystic fibrosis treatment as the first CFTR modulator for those with one F508del mutation.
We remind that this is not the only good news for Vertex. The stock has outperformed and will surely outperform better when other news comes out of the firm’s collaboration with the gene-editing firm CRISPR Therapeutics (CRSP).
Stay Tuned.
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AstraZeneca and Vertex Both Have Good News
AstraZeneca: Farxiga for Heart Failure with Reduced Ejection Fraction
AstraZeneca (AZN) has good news. Many of them are extremely positive. However, the firm’s stock is still struggling to get this pharmaceutical company out of the oversold territory where it has been living since the beginning of the year.
Among the recent good news came the results from a Phase 3 trial using AstraZeneca’s SGLT2 inhibitor product Farxiga for patients with reduced ejection fracture, with and without Type-2 diabetes. The trial known as DAPA-HF met the primary composite endpoint with a statistically significant and clinically meaningful reduction of cardiovascular death or the worsening of heart failure compared to placebo.
According to AstraZeneca Farxiga is the first in its class to show efficacy and safety data for patients with heart failure, with and without Type-2 diabetes, on top of standard of care.
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