FDA Approves BTG's Varithena for Treatment of Varicose Veins

November 26, 2013—BTG plc (London, UK) announced that the US Food and Drug Administration (FDA) has approved Varithena (polidocanol endovenous microfoam), which is indicated for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein (GSV) system. The company plans to launch Varithena in the United States during the second quarter of 2014. Formerly known as Varisolve, Varithena is a pharmaceutical-grade, low-nitrogen, polidocanol foam dispensed from a proprietary canister device.

According to BTG, in the two pivotal, placebo-controlled phase III trials, VANISH-1 and VANISH-2, Varithena demonstrated 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.

Whereas current treatments for varicose veins include thermal ablation and surgery, Varithena provides 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, nonsurgical procedure that requires neither tumescent anesthesia nor sedation, stated the company.

BTG noted that Varithena is polidocanol injectable foam that is a sclerosing agent indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee. Varithena improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

Varithena is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities. The use of Varithena is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease. Varithena can cause venous thrombosis. Full prescribing information for Varithena is available online at www.varithena.com.

The company advised that physicians administering Varithena must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease, and be trained in the administration of Varithena.