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Women Suffering From Myoma Could Avoid Surgery As EC Approves RICHTER Tablets

By Tamás Székely // 2015.05.29.

Hungary-based drugmaker company Gedeon Richter Plc. announced on Thursday, that the European Commission (EC) has granted approval for the intermittent use of the company’s ‘Esmya’ 5 mg tablets in the long term management of uterine fibroids. This decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 23 April 2015 and is applicable for all Member States in the European Economic Area.

„We are delighted with this significant step forward for Esmya, as it means more choice for physicians and patients in need of highly effective and convenient medical therapy for women suffering from uterine fibroids”, said Erik Bogsch, Richter’s managing director. „We remain committed to the development of female healthcare products which improve quality of life for the female population in all age groups”, he added. The initial marketing authorization for Richter’s ‘Esmya’ tablets was granted for the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. 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 potentially avoid surgery.

Uterine fibroids are the most common benign, solid tumours of the female genital tract, affecting between 20% and 40% of women of reproductive age. The condition is characterized by excessive uterine bleeding, anaemia, pain, frequent urination or incontinence, and infertility. Uterine fibroids are commonly treated surgically. However, surgery may not be a suitable option for all patients, e.g. for medical or personal reasons or if the woman would rather wait that the symptoms of uterine fibroids decrease as result of menopause. Thus, there was a medical need for a long-term medical treatment of fibroids. The full product information of Richter’s ‘Esmya’ 5 mg tablets is publicly available both in the registers of the European Commission and of the National Institute of Pharmacy and Nutrition Register in Hungary together with their respective online sites: www.ema.europa.eu and www.ogyei.gov.hu.

Gedeon Richter Plc., headquartered in Budapest is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe. Richter’s consolidated sales were approximately EUR 1.1 billion, while its market capitalization amounted to EUR 2.1 billion in 2014. The product portfolio of Richter covers almost all important therapeutic areas, including gynaecology, central nervous system, and cardiovascular areas. Having the largest R&D unit in Central Eastern Europe, Richter’s original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise, Richter is a significant player in the female healthcare field worldwide. Richter is also active in biosimilar product development.

via richter.hu