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Health
See other Health Articles

Title: Hopes Build for New Novartis Heart Failure Drug
Source: [None]
URL Source: [None]
Published: Aug 7, 2014
Author: Ben Hirschler
Post Date: 2014-08-07 01:21:10 by Tatarewicz
Keywords: None
Views: 12

Test Yourself: What Adult Needs What Vaccine? Medscape...

LONDON (Reuters) - Expectations are building for a new heart failure drug from Novartis viewed as a likely multibillion-dollar seller, with two surveys of cardiologists published on Tuesday highlighting its potential.

A large clinical trial with LCZ696 was stopped early in March because the benefit to patients was overwhelmingly positive. Just how good the drug was will be disclosed at a medical meeting in Spain at the end of this month.

The size of the benefit is critical in determining how widely LCZ696 might be used to treat millions of patients with chronic heart failure.

LCZ696, a twice a day pill for heart failure, is a first in class medicine that acts in multiple ways on the neurohormonal systems of the heart, blocking receptors exerting harmful effects while simultaneously promoting protective mechanisms.

Known as an ARNI (Angiotensin Receptor Neprilysin Inhibitor) LCZ696 is thought to reduce the strain on the failing heart, promoting the ability of the heart muscle to recover.

There has been little progress in treating heart failure in recent years, leaving doctors dependent on old generic medicines which do not work that well.

Heart experts polled separately by Deutsche Bank and Cowen both predicted Novartis's PARADIGM-HF trial would show an important reduction in the risk of cardiovascular death among patients taking LCZ696 versus those on a standard ACE inhibitor.

A survey of 25 cardiologists by Cowen found that, on average, they expected the relative risk reduction in the trial would be 23%, as measured by heart failure hospitalizations and mortality.

A similar-sized poll by Deutsche Bank concluded that a 15% or more benefit would be highly relevant and a result above 20% could prompt use of the drug in patient groups beyond those selected for the PARADIGM-HF trial.

Novartis has said LCZ696 could achieve annual peak sales of between $2 billion and $5 billion, or more.

But the company has also cautioned investors not to expect too much in terms of risk reduction, since LCZ696 was tested against an active drug, rather than a placebo pill - and the ACE inhibitor used as a control had already produced a risk reduction of 16% over a placebo in earlier tests.

"We don't know what the numbers look like but if you did have a 15 to 16% reduction in relative risk ... that would be a number that translates to a pretty darn big drug," Novartis Chief Executive Joe Jimenez said in a post-results call last month.

Full results on LCZ696 will be presented in Barcelona on Aug. 31 at the annual meeting of the European Society of Cardiology, which has already described the study as a highlight of the event.

While the PARADIGM-HF study targeted patients with reduced ejection fraction affecting the left side of the heart, Novartis is also starting a trial in a similar-sized group with preserved ejection fraction.

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