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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 treatmentEsmya(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. The PRAC is expected to make its final recommendations – to the EMA’s drug evaluation committee, the CHMP – following the meeting. If it does so, these will be forwarded to the European Commission for a legally binding decision. 

In February, as part of the review, the PRAC recommended that women taking Esmya should undergo liver function tests at least once a month, and that if the test results were abnormal (liver enzyme levels more than twice the upper limit of normal) treatment should be stopped, with liver tests repeated two to four weeks later. (Also see "Richter’s Uterine Fibroid Drug Esmya Hit By Liver Safety Concerns In EU" - Pink Sheet, 22 Feb, 2018.)

The temporary safety measures were introduced after a further report of hepatic failure requiring liver transplant with Esmya was received. They included advice that no new patients should be started on Esmya, and that those who had completed a course of treatment should not start another one pending the outcome of the review.

Gedeon Richter said at the time that it expected sales of Esmya to fall by at least 50% as a result of the restrictions, although it insisted that there was no evidence so far of a causal link between Esmya and the liver problems in question. It added that the most likely outcome of the review would be changes to the product information and the introduction of liver tests. (Also see "Richter Expects Esmya Sales To Drop 50% Following EU Restrictions Over Liver Concerns " - Scrip, 23 Feb, 2018.).

Gedeon Richter partner Allergan is seeking approval of Esmya in the US. The EMA review into liver damage prompted the Food and Drug Administration to push back the date by which a decision was due on new drug application by three months to August. (Also see "Keeping Track: Delay (For Celgene), Delay (For Allergan), Goose! (Approval For Lilly)" - Pink Sheet, 4 Mar, 2018.)

 EMA'S REVIEW OF ESMYA

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. The PRAC is expected to make its final recommendations – to the EMA’s drug evaluation committee, the CHMP – following the meeting. If it does so, these will be forwarded to the European Commission for a legally binding decision. 

In February, as part of the review, the PRAC recommended that women taking Esmya should undergo liver function tests at least once a month, and that if the test results were abnormal (liver enzyme levels more than twice the upper limit of normal) treatment should be stopped, with liver tests repeated two to four weeks later. (Also see "Richter’s Uterine Fibroid Drug Esmya Hit By Liver Safety Concerns In EU" - Pink Sheet, 22 Feb, 2018.)

The temporary safety measures were introduced after a further report of hepatic failure requiring liver transplant with Esmya was received. They included advice that no new patients should be started on Esmya, and that those who had completed a course of treatment should not start another one pending the outcome of the review.

Gedeon Richter said at the time that it expected sales of Esmya to fall by at least 50% as a result of the restrictions, although it insisted that there was no evidence so far of a causal link between Esmya and the liver problems in question. It added that the most likely outcome of the review would be changes to the product information and the introduction of liver tests. (Also see "Richter Expects Esmya Sales To Drop 50% Following EU Restrictions Over Liver Concerns " - Scrip, 23 Feb, 2018.).

Gedeon Richter partner Allergan is seeking approval of Esmya in the US. The EMA review into liver damage prompted the Food and Drug Administration to push back the date by which a decision was due on new drug application by three months to August. (Also see "Keeping Track: Delay (For Celgene), Delay (For Allergan), Goose! (Approval For Lilly)" - Pink Sheet, 4 Mar, 2018.)

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