U.S. FDA panel backs Scios heart failure drug
(UPDATE: Refiling, corrects typo in paragraph 4)
(UPDATE: recasts; adds details, background)
By Lisa Richwine
BETHESDA, Md., May 25 (Reuters) - Scios Inc. (Nasdaq:SCIO - news) moved closer to getting its first drug on the U.S. market on Friday, as an advisory panel unanimously backed approval for Natrecor, a heart failure treatment regulators rejected two years ago but analysts say could have sales of up to $300 million a year.
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A Food and Drug Administration (FDA) panel voted that Natrecor should be approved for treating acute flare-ups of congestive heart failure, a life-threatening condition that is the leading cause of hospitalization in Americans older than 65.
Scios, a Sunnyvale, Calif.-based biopharmaceutical company, hopes Natrecor will become its first product approved for marketing in the United States. Industry analysts estimate peak annual sales could be between $200 million and $300 million.
The committee vote ``was beyond our expectations. A unanimous vote is rare in this business,'' said Scios Chief Scientific Officer George Schreiner said in an interview.
The FDA usually follows its panels' advice, although its action was at odds with the committee on Scios' first request for approval. In January 1999, the advisory committee voted 5-3 to recommend approval, but the FDA turned down Scios' application and asked for more information.
To meet the FDA's demands, Scios compared Natrecor to nitroglycerin and a placebo in a trial of 489 patients. The study showed that Natrecor worked better than intravenous nitroglycerin, the standard treatment, at easing blood flow and helping patients breathe better, Scios officials said.
An estimated 5 million Americans, most of them elderly, have congestive heart failure, a chronic condition that causes fatigue and shortness of breath when fluid backs up into the lungs and tissues. Leading causes are damage to heart muscle from coronary artery disease or high blood pressure.
Missing a dose of daily medication or eating a heavy meal can send patients to the hospital with acute flare-ups. Scios said such episodes lead to 1 million hospital visits each year. The last new treatment for acute congestive heart failure was approved in 1987, and all current options have drawbacks such as possibly serious side effects.
Natrecor, known generically as nesiritide, is a genetically engineered version of a natural heart hormone that works by dilating blood vessels and easing blood flow. |
