Gedeon Richter says that sales of Esmya (ulipristal acetate), its treatment for uterine fibroids, are expected to fall by at least 50% as a result of restrictions placed on the product by the European Medicines Agency following several reports of serious liver injury and hepatic failure in women taking the product. However, the company says there is so far no evidence of a causal link between Esmya use and the liver problems in question.
Earlier this month, as part of a review of the safety profile of Esmya that began in December, the EMA’s...
