PRAC Recommends Marketing Authorization of Ulipristal Acetate be Revoked

September 10, 2020
BioPharm International Editors

PRAC has recommended the marketing authorization of ulipristal acetate for the treatment of uterine fibroids be revoked.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has issued its recommendation to revoke the marketing authorization of 5-mg ulipristal acetate (Esmya and generic medicines) for the treatment of uterine fibroids.

According to a Sept. 4, 2020 press release, PRAC has confirmed that ulipristal acetate can cause liver injury after considering all available evidence, including reported cases of serious liver injury. During the review, patient and healthcare professional representatives were also consulted.

As it has not been possible to identify patients that are more at risk of liver injury, including serious liver injury, that would enable the risk to be reduced of using the medicine, PRAC has concluded that 5-mg ulipristal acetate should not be marketed in the European Union. The use of the medicines had already been suspended while the review was being performed.

PRAC’s recommendation will now be forwarded to EMA’s Committee for Medicinal Products for Human Use (CHMP).

Source: EMA