FDA Approves Varithena to Treat Varicose Veins

The FDA recently approved BTG plc's Varithena (polidocanol injectable foam) for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein (GSV) system.

Varithena (formerly known as Varisolve PEM) is a pharmaceutical-grade, low-nitrogen, polidocanol foam dispensed from a proprietary canister device. In two pivotal, placebo-controlled Phase III trials, VANISH-1 and VANISH-2, Varithena achieved a clinically meaningful improvement in the symptoms of superficial venous incompetence and the appearance of visible varicosities and addressed the underlying venous incompetence in the majority of patients treated, according to the company.

Current treatments for varicose veins include thermal ablation and surgery. Varithena provides US physicians with the only approved comprehensive therapy to improve symptoms and appearance for a wide range of varicose veins, including incompetent GSV, accessory saphenous veins and visible varicosities of the GSV system both above and below the knee. Treatment is a minimally invasive, non-surgical procedure that requires neither tumescent anesthesia nor sedation.

Louise Makin, CEO at BTG, said: “We are delighted to receive US approval for Varithena, which we believe sets a new standard for the treatment of both the symptoms and appearance of varicose veins. We look forward to the commercial US 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.”