February 21 2014
BTG announces Varithena™ data demonstrating continued improvement at one year at the American Venous Forum Annual Meeting
London, UK, 21 February 2014
Data show clinically meaningful, ongoing improvements in patients with varicose veins caused by saphenofemoral junction incompetence
Today at the 26th Annual Meeting of the American Venous Forum in New Orleans, LA, Dr. Kenneth Todd, an American College of Phlebology Committee Member from the Southeast Vein and Laser Center and a Principal Investigator for VANISH-2, presented one-year data from the VANISH-2 clinical trial, one of the two pivotal trials for Varithena™ (polidocanol injectable foam). Varithena™, which was developed by the specialist healthcare company BTG, received US approval from the FDA in November 2013 for the treatment of varicose veins caused by saphenofemoral junction (SFJ) incompetence. Commercial launch in the US is planned in the second quarter of this year.
One-year results from VANISH-2, a study in which patients with symptomatic and visible varicose veins caused by saphenofemoral junction (SFJ) incompetence were treated with Varithena™, indicate that treatment with Varithena™ led to clinically meaningful and ongoing improvements in symptoms, as measured by the VVSymQ® score.
The VVSymQ® electronic daily diary is the first and only patient-reported outcomes instrument that measures the burden of varicose vein symptoms developed in accordance with FDA guidelines. The VVSymQ® score measures the five most relevant symptoms to patients: heaviness, achiness, swelling, throbbing, and itching. VVSymQ® scores range from 0 to 25, where 0 represents no symptoms and 25 represents all 5 symptoms experienced all of the time.
At baseline, 12% of patients treated with Varithena™ 1% reported a VVSymQ® score of 3 or less, whereas 84% of patients reported a VVSymQ® score of 3 or less at Year 1. The mean improvement in VVSymQ® score relative to baseline was 4.7 points at Week 8 and 6.2 points at Year 1.
Continued improvement at Year 1 was also shown in:
Appearance, as measured by a blinded independent panel review of photographs (IPR-V3) and a patient-reported outcome instrument (PA-V3),
Disease severity, as measured by the Venous Clinical Severity Score (VCSS), and
Varicose vein-related quality of life, as measured by the Venous Insufficiency Epidemiological and Economic Study−Quality of Life (VEINES-QOL) score.
Serious adverse events reported in the long-term follow-up period were typical of those that would be expected of the patient population studied and were unrelated to treatment.
“The one-year data from VANISH-2 are important because they show that clinically meaningful improvements in symptoms and appearance are sustained one year after treatment,” said Dr. Kenneth Todd, MD, “On-going improvements as shown in the VANISH-2 analysis support the recent FDA approval of Varithena™, which offers a new treatment option for patients with varicose veins.”
Varithena™ (polidocanol injectable foam) is the first and only FDA–approved foam for the treatment of incompetent veins and visible varicosities of the great saphenous vein (GSV) system. Varithena™ improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.1
Varithena™ is a low-nitrogen (less than 0.8%) foam with controlled properties for consistent performance. Varithena™ has been studied in over 1,300 patients in 12 clinical trials, including two Phase III placebo-controlled trials, VANISH-1 and VANISH-2.
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 www.btgplc.com.
IMPORTANT SAFETY INFORMATION ABOUT VARITHENA™
For more complete information about the use of Varithena™, please see the full Prescribing Information available at Varithena.com.
Varithena™ (polidocanol injectable foam) is a prescription medicine used to treat varicose veins and the associated affected veins in the great saphenous vein (GSV) system. Varithena™ can be used to treat veins above and below the knee. Varithena™ improves varicose vein symptoms and appearance.
IMPORTANT SAFETY INFORMATION FOR PATIENTS
Varithena™ is administered by a doctor and is for intravenous use only in the affected veins. Doctors must be trained in the administration of Varithena™.
You should not receive Varithena™ if:
you have a known allergy to polidocanol,
you have an acute vein or blood clotting disease, or
you are pregnant.
Warnings and Precautions
Because severe allergic reactions, including anaphylactic reactions, have occurred with other forms of polidocanol, patients should be observed for such reactions for at least 10 minutes following injection with Varithena™.
Injection of polidocanol into arteries or into the tissue outside the vein can cause severe necrosis, ischemia, or gangrene. If Varithena™ is injected into an artery, a vascular surgeon should be consulted immediately.
Varithena™ can cause blood clots (venous thrombi). 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 blood clots.
No specific drug interaction studies have been performed. There are no known drug interactions with Varithena™.
In clinical trials, the most common side effects (occurring in 3% or more of patients treated with Varithena™) were leg pain/discomfort, retained coagulum (pocket of blood in the treated vein), injection site hematoma (bruise) or pain, superficial thrombophlebitis (clot in a superficial vein) and extravasation (accidental administration of drug outside the vein).
Varithena™ prescribing information. Provensis Ltd, a BTG International group company. November 2013.
Varithena is a trademark of Provensis Ltd. VVSymQ, BTG, and the BTG roundel logo are registered trademarks of BTG International Ltd. Provensis Ltd and BTG International Ltd are BTG International group companies.
For further information please contact:
Ashley Tapp, Communications Manager, UK/Europe
+44 (0)20 7575 1513; Mobile: +44 (0)7790 811554
Courtney Prizer, Account Supervisor, United States
Melissa Scherkoske, Senior Vice President, United States