Ulipristal Suspended In EU Pending Further Review
Action Prompted By Another Case Of Serious Liver Injury
Gedeon Richter's Esmya should not be prescribed to women while the European Medicines Agency again reviews the risk of serious hepatic injury.
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Marketing authorizations for Gedeon Richter’s Esmya and generic versions are certain to be revoked, after a review by the European Medicines Agency’s safety committee concluded that the uterine fibroids drug “can cause liver injury, including the need for liver transplantation.”
Gedeon Richter has high ambitions for biosimilars, recently penning a deal to bring in a tocilizumab biosimilar that is currently under development. During its first-quarter earnings call, the Hungarian company’s CEO gave his current thinking on how payers may treat biosimilars amidst the COVID-19 pandemic.
The European Medicines Agency’s pharmacovigilance committee has recommended more restrictions on the use of Richter’s Esmya because of concerns over the risk of serious liver damage.