Nonsurgical Varicose Vein Treatment OKd by FDA

Tuesday, 26 Nov 2013 12:12 PM

 

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British pharmaceutical firm BTG said U.S. regulators had approved its varicose vein treatment that uses an injectable foam to dissolve the veins as an alternative to surgical removal.

Varithena, previously known as Varisolve, has taken more than a decade to win approval, as the company had to answer concerns that the active agent in the product polidocanol could enter the bloodstream.

The company, which had expected a decision from the Food and Drug Administration (FDA) in the first half of next year, has previously said global sales of Varithena could reach $500 million a year.

Chief Executive Louise Makin said on Tuesday the product would set a new standard for the treatment of both the symptoms and appearance of varicose veins.

"We look forward to the commercial U.S. launch in the second quarter of 2014, and to continuing to advance our plans to expand use into other geographies and into non-symptomatic veins," she said.

Varicose veins, which can be painful, especially when standing, affect more than 30 million adults in the U.S. aged between 18 to 70, with women twice as likely as men to develop the condition, BTG said.

Current treatments include surgically stripping or closing the vein using laser or heat treatments.

BTG said Varithena was minimally invasive and avoided the need for surgery and sedation. Its guidance for the product focuses on the medical market, rather than any potential cosmetic use, which analysts say could be a significant opportunity.

The group decided in 2010 to market the product itself in the United States rather than sharing development costs with a partner.
 

© 2014 Thomson/Reuters. All rights reserved.

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