Richter Expects Esmya Sales To Drop 50% Following EU Restrictions Over Liver Concerns
Restrictions placed on the use of Gedeon Richter’s uterine fibroid drug Esmya by the European Medicines Agency could significantly dent the product’s sales in the EU, and could also have a knock-on effect in the US, where the FDA accepted an NDA filing for the drug in October 2017.
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Sales of the uterine fibroid therapy, Esmya, sharply declined during the first half of 2018 at Hungary's specialty pharmaceuticals company, but an EU review of a potential association between the drug and liver injury has now been completed.
Chairman/CEO Saunders says the board has determined that keeping him in the dual role is the right move going forward. He added that the company, which had a strong second quarter, won’t be rushed in its efforts to divest its women’s health and infectious disease units.
Gedeon Richter’s uterine fibroid drug, Esmya (ulipristal acetate), is expected to be the subject of a safety recommendation by the EMA’s pharmacovigilance committee this week.