EMA’s human medicines committee (CHMP) has recommended restricting use of medicines containing ulipristal acetate 5 mg (Esmya and generic medicines) as a result of cases of serious liver injury. The medicines can now only be used to treat uterine fibroids in premenopausal women for whom surgical procedures (including uterine fibroid embolisation) are not appropriate or have not worked. The medicines must not be used for controlling symptoms of uterine fibroids while awaiting surgical treatment.
(Reuters) - AbbVie Inc said on Wednesday it was voluntarily withdrawing its drug to treat noncancerous growths in the uterus from the Canadian market, following reports of severe liver injury.
(Reuters) - AbbVie Inc said on Wednesday it was voluntarily withdrawing its drug to treat noncancerous growths in the uterus from the Canadian market, following reports of severe liver injury.
Health Canada Issues Recall of Allergan Canada`s Fibristal 5MG
OTTAWA – Health Canada continues to monitor safety information involving Fibristal (ulipristal acetate) as it does for all health products on the Canadian market. The Department is again reviewing the risk of serious liver injury associated with Fibristal, in response to a new international case of liver injury that led to a liver transplantation, and the European Medicines Agency’s recommendation to revoke the marketing authorization of the ulipristal acetate medication called Esmya in Europe.
The EMA’s PRAC has recommended the revocation of the marketing authorisation for ulipristal acetate, after a review confirmed liver injury caused by the medicine.
A review by EMA’s safety committee (PRAC) has confirmed that 5-mg ulipristal acetate (Esmya and generic medicines) used for the treatment of symptoms of uterine fibroids can cause liver injury, including the need for liver transplantation. The PRAC has therefore recommended the revocation of the marketing authorisations of these medicines.
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).
Allergan has grappled with numerous setbacks and plenty of investor uproar in recent years, but so far it's resisted serious change. But now, the company seems ready to embark on a split, according to analysts.
A phase 3 trial of Myovant Sciences' uterine fibroid drug relugolix has hit its primary endpoint, moving the Roivant unit a step closer to a planned filing for approval. The drug comfortably beat placebo against a slew of efficacy endpoints and posted comparable safety and tolerability to the control.