According to a press release from Gedeon Richter, the approval came after several levels of successful clinical trials.
“The present extension of indication adding the intermittent treatment courses of Esmya provides an opportunity to women to benefit from long-term medical management of uterine fibroids and to potentially avoid surgery,” the release said. “Uterine fibroids are the most common benign, solid tumours of the female genital tract, affecting between 20% and 40% of women of reproductive age.”
Gedeon Richter is Hungaryʼs leading drug company and a major pillar in the Budapest Stock Exchange, with a reported market capitalisation of €2.1 billion in 2014. The company boasts the largest research and development unit in Central and Eastern Europe.
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