Tags: Northera | blood pressure | neurogenic orthostatic hypotension

Anti-Fainting Drug OKd by Federal Panel

Wednesday, 15 Jan 2014 12:14 PM


Chelsea Therapeutics International Ltd. (CHTP)won the backing of U.S. advisers for its drug to prevent sudden drops in blood pressure, a boost for the company’s effort to bring its first product to market.
The drug, Northera, should be approved, the advisory panel voted 16-1 today at a meeting in Silver Spring, Maryland. The Food and Drug Administration, which isn’t bound by the recommendation, may decide by Feb. 14 on whether Northera can be sold to treat neurogenic orthostatic hypotension.
Chelsea shares had plunged 29 percent on Jan. 10 after an FDA staff report said that the company’s data didn’t answer questions the agency posed about long-term efficacy. Many panel members who voted in favor of approval said Chelsea showed the drug works short-term, and that initially is enough for such a rare, devastating disease with no other treatment options.
“I tend to lower the standard a little bit if there’s nothing else that really works,” Michael Proschan, a panelist who is a mathematical statistician at the National Institute of Allergy and Infectious Diseases, said after the vote.
Many panelists who voted in favor of the drug also recommended approval be conditioned on Chelsea proving Northera works longer than a week, which is as far as current data extends.
Second Chance
Trading in shares of the Charlotte, North Carolina-based company was halted today pending the outcome of the vote. The stock fell 8 percent yesterday to $2.30.
The FDA rejected Chelsea’s first attempt to bring Northera to market in March 2012, even after an advisory panel then voted to give the medicine its support based on unmet patient need. An FDA reviewer featured in the Jan. 10 report, Shari Targum, had questioned whether the new data proved the drug worked better than a placebo after one week, the same issue FDA workers raised when Chelsea first sought Northera approval.
Neurogenic orthostatic hypotension, which can cause sudden blood pressure drops and fainting, is common in the elderly and people with disorders such as Parkinson’s disease. Chelsea estimates almost 300,000 people suffer from the condition chronically in the U.S. and EU.
 

© Copyright 2017 Bloomberg News. All rights reserved.

 
1Like our page
2Share
Health-News
Chelsea Therapeutics International Ltd. (CHTP)won the backing of U.S. advisers for its drug to prevent sudden drops in blood pressure, a boost for the company's effort to bring its first product to market. The drug, Northera, should be approved, the advisory panel voted...
Northera,blood pressure,neurogenic orthostatic hypotension
351
2014-14-15
Wednesday, 15 Jan 2014 12:14 PM
Newsmax Inc.
 

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

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
© Newsmax Media, Inc.
All Rights Reserved