EMA recommends pulling ulipristal acetate for fibroids

Regulatory NewsRegulatory News | 04 September 2020 |  By 

An oral treatment for uterine fibroids should have its European Union marketing authorization revoked, according to the safety committee of the European Medicines Agency (EMA).
Citing the possibility of serious liver injury from ulipristal acetate, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended the revocation of marketing authority for the 5 mg oral tablets, which are marketed as Esmya and generics. The medication was authorized in the EU to treat moderate to severe symptoms of uterine fibroids, to be used for up to 3 months before surgery or for long-term use with intervals of treatment cessation.
The medication has also been authorized for single-dose use as emergency contraception under the trade name ellaOne, among others; this authorization is unaffected since “there is no concern about liver injury with these medicines” according to the EMA’s announcement.
The recommendation from PRAC comes after the committee “considered all the available evidence in its review, including reported cases of serious liver injury.” In the end, because it is not possible to identify which patients are at risk of liver injury from ulipristal acetate, PRAC decided that the risks outweighed benefits and recommended the revocation.
In March of this year, PRAC had already recommended suspension of marketing authorizations for the uterine fibroid-indicated formulations of ulipristal acetate pending review; the European Commission followed through with a suspension on 25 March 2020.
Ulipristal acetate was authorized in the EU in 2012 and underwent a previous review in 2018 that was prompted by “reports of serious liver injury” including liver failure requiring transplantation.
After that review PRAC concluded that ulipristal acetate use for uterine fibroids “may have contributed to the development of some cases of serious liver injury.” EMA therefore recommended in 2018 that the medication be contraindicated in those with known liver problems and restricted to just one course of treatment, except for women who were not eligible for uterine fibroid surgery. Additionally, the agency recommended obtaining liver enzyme levels at baseline, during treatment and after stopping treatment.
The recommendation for revocation of marketing authorization will now go before EMA’s Committee for Medicinal Products for Human Use (CHMP), who will forward their opinion to the European Commission, which will issue a legally binding decision.


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