WC500185968

Although the PRAC recognised the relevance of the documentation provided by the MAH and agreed
that the risk of a sustained dissemination of a variant of a vaccine strain is low, the PRAC considered
that, due to the increasing exposure to Rotarix over time and geographical area, a more systematic
study of shifts and drifts in vaccine derived rotavirus strains should be implemented until new evidence
provides a higher level of assurance that the Rotarix strains are stable over time. The PRAC considered
that a post-authorisation safety study will be necessary, with the primary objective to detect the
potential occurrence of genetic drift and shift in vaccine viral strains. Core requirements for this study
have been agreed by the PRAC and a new list of questions to the MAH was endorsed by the PRAC. The
PRAC in addition agreed to refer the issue to the CHMP and to the Vaccine Working Party (VWP) for
further evaluation.
7.5. Others
7.5.1. Ferumoxytol – RIENSO (CAP)
Evaluation of a PASS feasibility study
Regulatory details:
PRAC Rapporteur: Martin Huber (DE)
Administrative details:
Procedure number(s): EMEA/H/C/002215/MEA 017
Procedure scope: Evaluation of European databases for studies evaluating the risk of hypersensitivity
reactions in users of intravenous iron compounds (database feasibility evaluation report)
MAH(s): Takeda Pharma A/S
See also under 11.3.
Background
Rienso, a centrally authorised medicine, is a colloidal iron-carbohydrate complex indicated for the
intravenous treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD).
As part of the RMP for Rienso, following the assessment of PSUV/014 (see PRAC Minutes July 2014)
and in line with the outcome of the Article 31 referral procedure on intravenous iron-containing
medicinal products (EMEA/H/A-31/1322), there was a request to conduct a post-authorisation safety
study (PASS) to further characterise the safety concerns relating to serious hypersensitivity reactions
(category 1 study).
The MAH submitted a database feasibility evaluation report (evaluation of European databases for
studies evaluating the risk of hypersensitivity reactions in users of intravenous iron compounds) for
this PASS.
Summary of advice
The PRAC discussed the database feasibility evaluation report submitted by the MAH and agreed that
whilst the MAH is correct that there are limitations when evaluating the risk of anaphylaxis in the
databases identified, other databases need to be considered as does the possibility to complement
data from healthcare databases with information to be obtained through other methods. The PRAC
supported the Rapporteur’s comments regarding the anticipated sample size and ways to enhance it,
the frequency of anaphylaxis / hypersensitivity reactions, as well as the need for case verification in
this particular study.
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 49/89