Promising Heart Failure Drug Fast-Tracked for Approval

Friday, 21 Jun 2013 08:01 AM

 

  Comment  |
   Contact  |
  Print   |
    A   A  
  Copy Shortlink
Novartis AG won “breakthrough”status from U.S. regulators for an experimental drug to treat acute heart failure, raising the prospect of faster approval.
 
Serelaxin, a man-made version of a hormone found in pregnant women, reduced death rates by 37 percent in patients with acute heart failure six months after treatment, according to clinical trial results presented last year.
 
Also known as RLX030, The drug is Basel, Switzerland-based Novartis’s second to receive the new designation from the U.S. Food and Drug Administration after the lung-cancer treatment LDK378. Faster approvals of the two drugs would provide a sales boost for Novartis, Europe’s biggest drugmaker, just as the company’s best-selling products are losing patent protection.
 
“Commonly used medicines for AHF only improve the immediate symptoms, so the additional effect on survival observed with RLX030 offers hope to patients and physicians,” David Epstein, division head of Novartis Pharmaceuticals, said in a statement Friday.
 
Novartis’s Diovan hypertension drug started to lose patent protection last year. Gleevec, a cancer treatment, will be open to copies starting in 2015. Together, they generated $9.1 billion in sales last year. The company has filed for approval of Serelaxin in the U.S. and the European Union.
 
Other therapies that have received the breakthrough designation since it was established last year include Pfizer’s breast-cancer drug palbociclib and Johnson & Johnson and Pharmacyclics Inc.’s ibrutinib for certain types of blood cancer. Xalkori was approved in 2011, before the FDA program was introduced.
 
Acute heart failure often occurs in the wake of other ailments such as hypertension, diabetes or coronary artery disease and may strike about one in 10 people over the age of 65. Doctors now use a mix of drugs and devices to help patients feel better, yet half of those hospitalized don’t survive longer than five years. RLX030 is a manufactured copy of relaxin-2, a hormone whose levels rise during pregnancy.

© Copyright 2014 Bloomberg News. All rights reserved.

  Comment  |
   Contact  |
  Print   |
  Copy Shortlink
Around the Web
Join the Newsmax Community
Please review Community Guidelines before posting a comment.
>> Register to share your comments with the community.
>> Login if you are already a member.
blog comments powered by Disqus
 
Email:
Country
Zip Code:
Privacy: We never share your email.
 
Follow Newsmax
Like us
on Facebook
Follow us
on Twitter
Add us
on Google Plus
Around the Web
Top Stories
You May Also Like

New Test Predicts Heart Attack: Should You Get It?

Friday, 19 Dec 2014 13:05 PM

A simple, new blood test that accurately predicts whether a person is headed for a heart attack is a "game-changer" in h . . .

'Surveillance' Best Approach for Low-Risk Prostate Cancer: Study

Friday, 19 Dec 2014 12:39 PM

Among men whose low-risk prostate cancer was managed with so-called active surveillance for up to 15 years, just 1.5 per . . .

E-Cigs Less Addictive Than Regular Cigarettes, Say Researchers

Friday, 19 Dec 2014 12:35 PM

Former tobacco smokers find e-cigarettes less addictive than traditional cigarettes, new research finds. Even though the . . .

Most Commented

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

 
NEWSMAX.COM
America's News Page
©  Newsmax Media, Inc.
All Rights Reserved