FDA approves Varithena injectable foam for treating varicose veins

BTG announced today that the FDA has approved its polidocanol injectable foam for treating patients with incompetent veins and visible varicosities of the great saphenous vein system.

The FDA approval was based on two placebo-controlled phase 3 trials in which the “majority of patients treated” with Varithena, a sclerosing agent, achieved clinically meaningful improvement in superficial venous incompetence symptoms and visible varicosities appearance, while addressing the underlying incompetence, according to a press release.

Varithena is indicated for treating incompetent great saphenous veins, accessory saphenous veins and visible varicosities above and below the knee, the release said. The pharmaceutical-grade, low-nitrogen, polidocanol foam is injected intravenously, using ultrasound guidance, administered through a single cannula, according to the release.

While thermal ablation and surgery are current treatments for varicose veins, Varithena “is a minimally invasive, nonsurgical procedure that requires neither tumescent anesthesia nor sedation,” according to BTG.

“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 nonsymptomatic veins,” Louise Makin, BTG chief executive officer, said in the release.

Varithena can cause venous thrombosis and should not be used in patients with polidocanol allergy or acute thromboembolic disease, according to the release. Administration of liquid polidocanol has been associated with reports of severe allergic reactions, including anaphylactic reactions, some fatal.

Severe necrosis, ischemia and gangrene also have been reported with intra-arterial injection or extravasation of polidocanol, according to BTG.