FDA Approves Varithena
FDA Approves Varithena (Polidocanol Injectable Foam) for the Treatment of Patients with Varicose Veins
LONDON, November 26, 2013 /PRNewswire/ -- BTG plc (LSE: BTG), the specialist healthcare company, today announces that the US Food and Drug Administration (FDA) has approved Varithena (polidocanol injectable foam) for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein (GSV) system.(1)
Varithena (formerly known as Varisolve(R) 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(TM) 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.
More than 30 million adults in the US aged 18 to 70 have varicose veins, with women twice as likely as men to develop varicosities. Varicose veins often require treatment for symptoms including leg pain, aching, heaviness, restless legs, cramps, throbbing, fatigue, itchiness, tingling and oedema. These symptoms are frequently the cause of absenteeism from work, disability and decreased quality of life.(2)
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."
Varithena (polidocanol injectable foam) 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.
Important Safety Information
For intravenous use only. 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.
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.
The use of Varithena is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease.
Warnings and Precautions
Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately.
Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease, such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger's Disease) may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately.
Varithena can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis.
In clinical trials, the most common related adverse events (occurring in >=3% of patients treated with Varithena(TM)) were pain/discomfort in extremity, infusion site thrombosis (retained coagulum), injection site hematoma or pain, thrombophlebitis superficial, and extravasation.
Use in Specific Populations
Pregnancy Category C. Do not use Varithena in pregnant women.
See Full Prescribing Information for Varithena online at Varithena.com.
1. Varithena(TM) prescribing information. BTG International Inc. November 2013.
2. Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011;53(5 Suppl):2S-48S.
BTG is an international specialist healthcare company that is developing and commercializing products targeting acute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians. For further information about BTG please visit our website at http://www.btgplc.com.
Source: BTG plc
Posted: November 2013