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EMA Panel Finalises Safety Probe Into Richter’s Fibroid Drug Esmya

 
• By Ian Schofield

Gedeon Richter’s uterine fibroid drug, Esmya (ulipristal acetate), is expected to be the subject of a safety recommendation by the EMA’s pharmacovigilance committee this week.

Review
The EMA's review of Esmya could end in a safety recommendation this week

The European Medicines Agency’s pharmacovigilance committee, the PRAC, is due to adopt a recommendation this week on the safety of Gedeon Richter’s uterine fibroid treatment Esmya (ulipristal acetate). The drug has been the subject of reports of serious liver injury in women taking it.

The PRAC is carrying out a review of the benefit-risk balance of Esmya following a referral under Article 20 of Regulation (EC) No 726/2004, which concerns safety or manufacturing issues with pharmaceutical products. The committee's May meeting, which has been taking place this week in London, ends today

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