WC500169468

Germany, the PRAC considered that at present, there was no need to distribute an EU-wide DHPC to
provide recommendations on how to use the syringe to avoid potential cases of under-dosing. Instead,
communication will be agreed at national level.
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.
6.1.5. Exenatide – BYDUREON (CAP), BYETTA (CAP)
Evaluation of a PSUR procedure
Regulatory details:
PRAC Rapporteur: Qun-Ying Yue (SE)
Administrative details:
Procedure number(s): EMEA/H/C/002020/PSUV/0018, EMEA/H/C/000698/PSUV/0042 (without RMP)
MAH(s): Bristol-Myers Squibb/AstraZeneca EEIG
Background
Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination for the
treatment of type 2 diabetes mellitus under certain conditions.
Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of Bydureon and
Byetta, centrally authorised medicines containing exenatide, and issued a recommendation on their
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 Bydureon
and Byetta (exenatide) in the approved indication(s) remains favourable.
With regard to exenatide twice daily (Byetta), the current terms of the marketing
authorisation(s) should be maintained.
With regard to exenatide once weekly (Bydureon), the product information should be updated
to add injection site abscess and cellulitis as undesirable effects with an unknown frequency.
Therefore the current terms of the marketing authorisation(s) should be varied 15 .
In the next PSUR, the MAH should provide a detailed review of cases of increased liver
enzymes and of cases of cholecystitis/cholelithiasis and propose an update of the product
information as warranted. The MAH should continue to closely monitor cases of pancreatitis,
pancreatic cancer and thyroid cancer.
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. The frequency
of submission of the subsequent PSURs should be changed from 6-monthly to yearly and the list of
Union reference dates (EURD list) will be updated accordingly.
6.1.6. Ferumoxytol – RIENSO (CAP)
Evaluation of a PSUR procedure
15 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.
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 36/73