Temporary measures put in place while Gedeon Richter PLC's Esmya (ulipristal acetate) was reviewed by the EU's pharmacovigilance committee was one of two factors holding back the Hungarian company's sales growth during the first half of 2018. However, the review process for Esmya was completed on July 30, and has "opened the way for the relaunch of this product," the company says.
Esmya sales declined by 54.2% to €20.2m in the first half of 2018, as the EU's pharmacovigilance risk assessment committee (PRAC) implemented temporary measures that included stopping new patients being started on Esyma, and halting new courses of therapy being given, a fall forecast by the company some months ago
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