EMA Safety Commission Recommends Withdrawal Of Esmya Authorizations
Follows March Suspension By EMA
Marketing authorizations for Gedeon Richter’s Esmya and generic versions are certain to be revoked, after a review by the EMA’s safety committee concluded that the uterine fibroids drug “can cause liver injury, including the need for liver transplantation.”
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Hungary’s Gedeon Richter is continuing efforts to bring multiple biosimilars to market, while reaping the benefits of the biosimilar to Eli Lilly’s Forsteo (teriparatide) in the EU and Japan. Management discussed Richter’s achievements on the company’s first-half earnings call, while also commenting on how markets have reacted to the COVID-19 pandemic.
Gedeon Richter's Esmya should not be prescribed to women while the European Medicines Agency again reviews the risk of serious hepatic injury.
Alvogen has gained European approvals for a rival to Gedeon Richter’s Esmya through the decentralized procedure.