LONDON, Nov 26 (Reuters) - British pharmaceutical firm BTG said U.S. regulators had approved its groundbreaking varicose veins treatment that uses an injectable foam to dissolve the veins as an alternative to stripping.
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.
Shares in BTG, which also has interventional treatments for cancer, rose to a more than 11 year high of 521.5 pence after the announcement on Tuesday. They were trading up 13 percent at 519 pence by 1115 GMT.