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FDA Designates "Breakthrough Drug" for Heart Failure


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6/25/2013
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The Food and Drug Administration recently created the designation of "breakthrough therapy" to describe new drugs that may be released on the market and that provide vastly different results than other drugs already in existence.  Put differently, the drugs in this special category provide a new type of treatment previously unavailable for serious medical conditions.  The FDA just now has assigned this designation to a drug produced by Novartis, serelaxin, designed to treat patients with acute heart failure.  Results from drug trials show that it reduced deaths by 37% in patients 6 months after experiencing a heart episode compared to those who received standard therapy.  The drug is comprised of human relaxin-2, a naturally human hormone that enables the body to handle cardiovascular stress. The FDA and the European Medicines Agency (EMA) are among the numerous health agencies addressing the potential of this new drug before releasing it into the market.  Analysts note that the release of serelaxin could produce $2.5 billion in annual sales based on the promising outlook for success in treatment.



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