BTG gets FDA nod
pharmafile | November 29, 2013 | News story | Sales and Marketing | BTG, FDA, Varithena, varicose vein
UK healthcare group BTG has received approval from the FDA for a new type of varicose vein treatment to be used in the US and it is slated for launch before June 2014.
Varithena (polidocanol injectable foam) has travelled a long road to get to this point: trials were suspended in the US over worries that the microbubbles used in Varisolve treatment might obstruct local blood supply, causing microinfarcts.
In response to this huge setback, the company collected all data from its studies and submitted a report to the FDA in March 2005.
This contained information from a one-year programme of pre-clinical studies aimed at enabling resumption of the US development of Varithena (then known as Varisolve), together with the protocol for a proposed Phase II clinical study.
The FDA wanted amendments to this, which were submitted in May 2005, and the regulator relented in July that year, lifting the restriction on conducting clinical trials with Varisolve and approving the Phase II study protocol.
Phase III trials began in the US in 2010 and results from VANISH-1 and VANISH-2 have demonstrated success: BTG reckons it could see sales of $500 million per year from the product, which provides a less invasive alternative to current approaches such as laser treatment and surgery.
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, causing disability, decreased quality of life and absence from work.
Sufferers often require treatment for symptoms including leg pain, aching, heaviness, restless legs, cramps, throbbing, fatigue, itchiness, tingling and oedema.
Despite the FDA approval, doctors are warned that Varithena can cause venous thrombosis. It is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease.
“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,” said Louise Makin, chief executive of 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 non-symptomatic veins,” she added.
Adam Hill
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