FDA approves Pharma’s diabetes drug for heart failure

Dive Brief:​

  • Eli Lilly and partner Boehringer Ingelheim on Wednesday said the Food and Drug Administration has approved their diabetes drug Jardiance to treat patients with a specific type of heart failure.
  • Doctors can now prescribe the medication for heart failure patients with reduced ejection fraction, which happens when an enlarged heart muscle fails to contract properly and pumps less blood than needed into the body. It's a common form of heart failure, which overall affects more than 6 million Americans, according to the Centers for Disease Control and Prevention.
  • The FDA cleared the new use based on the companies' EMPEROR-Reduced study, which found treatment with Jardiance reduced the risk of cardiovascular death and hospitalization by 25% compared with a placebo. Researchers included patients with and without Type 2 diabetes and saw benefits for both groups.
 

Dive Insight:​

The expanded approval offers a significant boost for Jardiance, sales of which are already on track to top $1 billion this year. In the second quarter, revenue from the drug jumped 36% to about $357 million.

Lilly and Boehringer next have their eyes on approval for heart failure patients with preserved ejection fraction. The harder-to-treat condition occurs when the left ventricle can't properly relax, resulting in the heart being unable to fill with enough blood to pump out to the body even though it's still contracting normally.

Jardiance is the first medicine shown to reduce cardiovascular death and hospitalization for preserved ejection fraction patients in a late-stage study, according to Lilly. The company announced positive results from the trial in July, saying Jardiance showed a significant benefit, but didn't give details. Researchers plan to present results at the European Society of Cardiology meeting later this month.

If the detailed data are as promising as Lilly claims, Jardiance could become a widely used treatment for heart failure. Until an approval for Novartis' Entrestoin February, no drug was cleared for both reduced and preserved ejection fraction patients. Novartis won approval despite a trial that failed to meet its primary goal of significantly reducing heart failure hospitalizations and deaths.

Meanwhile, AstraZeneca is on the same path as Lilly and Boehringer, testing its diabetes drug Farxiga in patients with preserved ejection fraction. That studyis due to finish in January. The British drugmaker won an approval for Farxiga in reduced ejection fraction patients last May.
 
https://www.fiercepharma.com/pharma...ailure-nod-for-jardiance-another-one-possible

Staying relevant in the competitive heart failure market requires contenders to keep their products moving forward.


On Wednesday, Eli Lilly and Boehringer Ingelheim did just that for Jardiance, scoringan FDA approval to treat those with heart failure with reduced ejection fraction (HFrEF) regardless of whether they have Type 2 diabetes. It is the first indication for Jardiance outside the Type 2 diabetes arena.

The endorsement also allows Jardiance to play catch-up with AstraZeneca’s Type 2 diabetes drug Farxiga, which last year became the first SGLT2 inhibitor to score an FDA green light for heart failure patients whether or not they have diabetes.
 
Novartis' blockbuster Entresto is the most popular heart failure medication and can be used in combination with SGLT2 inhibitors. Another new contender for heart failure is Verquvo, a guanylate cyclase stimulator from Merck and Bayer that won its first approval in January, specifically for HFrEF patients.

HFrEF, which occurs when the heart muscle does not contract effectively and causes reduced blood flow to the body, accounts for more than half of the 60 million-plus heart failure cases worldwide.

Jardiance's new approval comes after the drug turned in positive results in the phase 3 Emperor-Reduced trial, which recruited 3,730 HFrEF patients. The trial showed that Jardiance reduced the risk of time to death or hospitalization by 25% against placebo. Jardiance also reduced the risk of first and recurrent hospitalization by 30% and retained its safety profile from its other indications.

“Around half of all people with heart failure, unfortunately, are expected to die within five years of diagnosis. The risk of death increases with each hospitalization,” Mohamed Eid, the head of clinical development and medical affairs of cardio-metabolism and respiratory medicine at Boehringer-Ingelheim said in the release.
 
Looking forward, Jardiance could be poised for an even more significant win in heart failure. In July, Lilly and Boehringer Ingelheim revealed data showing Jardiance’s effectiveness in heart failure patients with preserved ejection fraction (HFpEF). The companies expect to file for regulatory approvals by the end of this year.

With that nod in hand, Jardiance would become the only therapy to improve outcomes in all heart failure patients, regardless of ejection fraction status or whether they have Type 2 diabetes.

After that readout, market analysts at Cantor Fitzgerald warned investors not to overlook the drug's promise.

“We think the potential for Jardiance to treat cardiovascular disease could be a blockbuster opportunity that is still underappreciated,” wrote Louise Chen in a note to clients.

Investigators are presenting the detailed data readout for that trial next weekend at the European Society of Cardiology's annual congress.
 
ginfreely said:
The endorsement also allows Jardiance to play catch-up with AstraZeneca’s Type 2 diabetes drug Farxiga, which last year became the first SGLT2 inhibitor to score an FDA green light for heart failure patients whether or not they have diabetes.
Click to expand...

SGLT2 Inhibitors: A New Class of Diabetes Medications​

Sep 19, 2018


Author: David L. Joffe, BSPharm, CDE, FACA

What is a SGLT2 Inhibitor?​

Sodium-glucose co-transporter 2 (SGLT2) inhibitors, also called gliflozin drugs, are a new class of diabetic medications indicated for the treatment of type 2 diabetes. They have also been found to show cardiac benefits in patients with diabetes, and are being studied for possible use in type 1 diabetes. They work by reducing the absorption of glucose via the kidneys so that excess glucose is excreted through urination.
In conjunction with exercise and a healthy diet, they can improve glycemic control. They have been studied alone and with other medications including metformin, sulfonylureas, nizagara 100, pioglitazone, and insulin.
 
How SGLT2 Inhibitors Work

SGLT2 is a protein in humans that facilitates glucose reabsorption in the kidney. SGLT2 inhibitors block the reabsorption of glucose in the kidney, increase glucose excretion, and lower blood glucose levels.

SGLT2-1HIW
 
SGLT2 is a low-affinity, high capacity glucose transporter located in the proximal tubule in the kidneys. It is responsible for 90% of glucose reabsorption. Inhibition of SGLT2 leads to the decrease in blood glucose due to the increase in renal glucose excretion. The mechanism of action of this new class of drugs also offers further glucose control by allowing increased insulin sensitivity and uptake of glucose in the muscle cells, decreased gluconeogenesis and improved first phase insulin release from the beta cells.
 
Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood to meet the body's needs for blood and oxygen.31 May 2017

What is Heart Failure? | American Heart Association​

 
How long can you live with heart failure?


In general, about half of all people diagnosed with congestive heart failure will survive five years. About 30% will survive for 10 years. In patients who receive a heart transplant, about 21% of patients are alive 20 years later.
 
What are the different types of heart failure?
  • Left-sided heart failure. Left-sided heart failure is the most common type of heart failure. ...
  • Right-sided heart failure. The right heart ventricle is responsible for pumping blood to your lungs to collect oxygen. ...
  • Diastolic heart failure. ...
  • Systolic heart failure.
https://www.healthline.com/health/heart-failure
 

What causes heart failure?​

Heart failure is most often related to another condition. The most common cause of heart failure is coronary artery disease (CAD), a disorder that causes narrowing of the arteries that supply blood and oxygen to the heart. Other conditions that may increase your risk for developing heart failure include:

  • cardiomyopathy, a disorder of the heart muscle that causes the heart to become weak
  • congenital heart disease
  • heart attack
  • heart valve disease
  • certain types of arrhythmias, or irregular heart rhythms
  • high blood pressure
  • emphysema, a disease of the lung
  • diabetes
  • an overactive or underactive thyroid
  • HIV
  • severe forms of anemia
  • certain cancer treatments, such as chemotherapy
  • substance or alcohol misuse
 
What's the point everyone's going to die anyway.
 
Juicing, regular exercise, sex, maintaining an optimal weight where one can see the abs and ribs and a balanced lifestyle that does not stress one is more effective in treating most diseases than just medication
 
ginfreely said:
Then why you doing exercise for? Why don’t just do nothing and die?
Click to expand...

That's to maintain my quality of life while I'm still alive. Thanks to my exercise regime I can hold my own in most physical activities.

However once my heart or or some other organ is failing I see little point in taking drugs that do nothing but extend the misery.

If you look at the fine print you'll see that none of these drugs offers a cure. All they do is buy poor quality time for an astronomical price.
 
Leongsam said:
That's to maintain my quality of life while I'm still alive. Thanks to my exercise regime I can hold my own in most physical activities.

However once my heart or or some other organ is failing I see little point in taking drugs that do nothing but extend the misery.

If you look at the fine print you'll see that none of these drugs offers a cure. All they do is buy poor quality time for an astronomical price.
Click to expand...
How you know these drugs while do not offer a cure will not alleviate the symptoms of heart failure and improve the quality of life of the patient?
 
ginfreely said:
How you know these drugs while do not offer a cure will not alleviate the symptoms of heart failure and improve the quality of life of the patient?
Click to expand...

Because heart failure cannot be cured. Heart muscle cannot regenerate.
 
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