Esmya may now only be used to treat uterine fibroids in premenopausal women "for whom surgical procedures…are not appropriate or have not worked", Richter said.
Last September, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) had recommended revoking authorizations for the sale of products containing 5-mg ulipristal acetate, the active ingredient in Esmya, after a benefit-risk analysis, because it can cause liver injury. In November, CHMP endorsed PRAC's assessment of the risk of liver injury, but said the benefits of 5-mg ulipristal acetate may outweigh the risks in women who have no other treatment options. It recommended making the drug available to treat premenopausal women who could not have surgery or for whom surgery had not worked.
The CHMP recommendation was forwarded to the European Commission for its decision and the use of Esmya suspended, as a precaution, pending the outcome of the EC's review.
Esmya was earlier among Richter's best-selling products until restrictions were placed on sales after the EMA concluded that the drug may have contributed to the development of some case of serious liver injury. In 2019, Richter booked HUF 29 billion in impairment losses on Esmya.
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