Prospective, Inappropriate Esmya use in Final report noninterventional management of world” planned in Q1 “real study (PASS) endometrium practice 2023 (8 years PGL14-001: A thickening after variation prospective, (unnecessary approval) noninterventional interventions or study to evaluate treatments) the long term Inappropriate safety of Esmya, in diagnosis of particular the endometrial endometrial safety, hyperplasia and the current (mistaking PAEC prescription and for hyperplasia) management Acute uterine patterns of Esmya bleeding requiring in a long term immediate treatment setting. intervention (PREMIUM, category 3) Drug Induced Liver Injury (DILI) Treatment beyond three months Delayed diagnosis of atypical endometrial hyperplasia or adenocarcinoma Impact on surgery Clinical Long-term effects Safety and Final report in PGL11-024: A of prolonged efficacy in total Q3 2015 Phase III, treatment on the eight 3-month extension study of endometrium treatment repeated courses intermittent courses of open-label of 10 mg ulipristal acetate. (PEARL extension 2, category 3) RMP reviewer comment The existing, ongoing and planned pharmacovigilance activities are considered acceptable for the purposes of this submission. The sponsor should make the result of PEARL study (PGL11-024) available to TGA. Risk minimisation activities Sponsor’s conclusion in regard to the need for risk minimisation activities The sponsor is proposing additional risk minimisation activities.
Prospective, noninterventional study (PASS) PGL14-001: A prospective, noninterventional study to evaluate the long term safety of Esmya, in particular the endometrial safety, and the current prescription and management patterns of Esmya in a long term treatment setting. (PREMIUM, category 3) Inappropriate management of endometrium thickening (unnecessary interventions or treatments) Inappropriate diagnosis of endometrial hyperplasia (mistaking PAEC for hyperplasia) Acute uterine bleeding requiring immediate intervention Drug Induced Liver Injury (DILI) Treatment beyond three months Delayed diagnosis of atypical endometrial hyperplasia or adenocarcinoma Impact on surgery Esmya use in “real world” practice Final report planned in Q1 2023 (8 years after variation approval) Clinical PGL11-024: A Phase III, extension study of repeated intermittent courses of open-label of 10 mg ulipristal acetate. (PEARL extension 2, category 3) Long-term effects of prolonged treatment on the endometrium Safety and efficacy in total eight 3-month treatment courses Final report in Q3 2015 RMP reviewer comment The existing, ongoing and planned pharmacovigilance activities are considered acceptable for the purposes of this submission. The sponsor should make the result of PEARL study (PGL11-024) available to TGA. Risk minimisation activities Sponsor’s conclusion in regard to the need for risk minimisation activities The sponsor is proposing additional risk minimisation activities.
auspar-ulipristal-acetate-161019.docx