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Regulatory details: PRAC Rapporteur: Isabelle Robine (FR) Administrative details: Procedure number(s): EMEA/H/C/002392/PSUV/0011 MAH(s): Bayer Pharma AG Background Aflibercept is a recombinant fusion protein indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) and for visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO). Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of Eylea, a centrally authorised medicine containing aflibercept, and issued a recommendation on its marketing authorisation(s). Summary of recommendation(s) and conclusions Based on the review of the data on safety and efficacy, the risk-benefit balance of Eylea (aflibercept) in the approved indication(s) remains favourable. Nevertheless, the product information should be updated to include blindness and reduced visual acuity as undesirable effects with a frequency uncommon and very common respectively. Therefore the current terms of the marketing authorisation(s) should be varied 20 . In the next PSUR, the MAH should closely monitor cases of blindness and should provide further data, in particular, detailed analyses of cases of arterial thromboembolic events (ATE), cases of cataract with traumatic origin, fatal cases and cases of non-ocular haemorrhage. The next PSUR should be submitted in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC. 6.1.2. Anagrelide – XAGRID (CAP), NAP Evaluation of a PSUSA 21 procedure Regulatory details: PRAC Rapporteur: Isabelle Robine (FR) Administrative details: Procedure number(s): EMEA/H/C/PSUSA/00000208/201309 MAH(s): Shire Pharmaceutical Contracts Ltd. (Xagrid), Orpha-Devels Handels und Vetriebs GmbH, OAP Orphan Pharmaceuticals (Thromboreductin) Background Anagrelide is an inhibitor of the cyclic AMP phosphodiesterase III indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients under certain conditions. Based on the assessment of the individual PSURs part of the PSUR single assessment procedure (PSUSA), the PRAC reviewed the benefit-risk balance of anagrelide-containing products and issued a recommendation on their marketing authorisation(s). 20 Update of SmPC section 4.8. The package leaflet is updated accordingly. The PRAC AR and PRAC recommendation are transmitted to the CHMP for adoption of an opinion. 21 PSUR single assessment, referring to CAP, NAP Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 30/75
Summary of recommendation(s) and conclusions Based on the review of the data on safety and efficacy, the risk-benefit balance of anagrelidecontaining products in the approved indication(s) remains favourable. With regard to Thromboreductin, the product information should be updated to refine the current warning on monitoring, to add the need to closely supervise the level of electrolytes (potassium, magnesium and calcium) and to add a new warning on cardiovascular risks. In addition, torsades de pointe and tubulointerstitial nephritis should be added as undesirable effects with a frequency unknown. Finally, information on effects on heart rate and QTc interval should be added to the product information under pharmacodynamic properties. Therefore the current terms of the marketing authorisation(s) should be varied 22 . With regard to Xagrid, the current terms of the marketing authorisation(s) should be maintained. With regard to Xagrid, the MAH should submit to EMA within 90 days a variation to update the product information in sections dedicated to fertility, pregnancy and lactation and preclinical safety data with newly available non-clinical data. With regard to Thromboreductin, revisions of the product information will have to be considered at the national level where the medicinal product is authorised, once the variation procedure for Xagrid is finalised. In the next PSURs for all anagrelide-containing products, MAHs should closely monitor cardiac events in young patients (aged 50 years and under), cardiac events related to QTc prolongation and torsade de pointes, thrombohaemorrhagic events, benign or malignant neoplasms including myelofibrosis, pulmonary adverse events from the interstitial lung disease and cases of exposure during pregnancy. The next PSUR should be submitted in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC. 6.1.3. Boceprevir – VICTRELIS (CAP) Evaluation of a PSUR procedure Regulatory details: PRAC Rapporteur: Isabelle Robine (FR) Administrative details: Procedure number(s): EMEA/H/C/002332/PSUV/0028 MAH(s): Merck Sharp & Dohme Limited Background Boceprevir is an inhibitor of the hepatitis C virus (HCV) non-structural protein 3 (NS3) indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of Victrelis, a centrally authorised medicine containing boceprevir, and issued a recommendation on its marketing authorisation(s). 22 Update of SmPC sections 4.4, 4.8 and 5.1. The package leaflet is updated accordingly. The PRAC AR and PRAC recommendation are transmitted to the CHMP for adoption of an opinion. Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 31/75
Page 1 and 2: 10 July 2014 EMA/PRAC/438418/2014 P
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