WC500185968

Administrative details:
EPITT 18109 – Follow-up November 2014
Procedure number(s): EMEA/H/C/000690/SDA/033
MAH(s): Bayer Pharma AG
Background
For background information, see PRAC Minutes November 2014. The MAH replied to the request for
information on the signal of acute generalised exanthematous pustulosis (AGEP) and the responses
were assessed by the Rapporteur.
Discussion
The PRAC discussed the cumulative review of the signal of AGEP provided by the MAH. One case of
AGEP referring to a publication by Pretel et al. (2014) was not typical as there was no fever, but was
accepted as confirmed. Causality in relation to sorafenib, however, may be questioned due to negative
patch tests and the longer than expected duration of exposure to sorafenib prior to the event. Further
search in clinical studies, databases and the literature revealed one case of clinically diagnosed,
atypical case of AGEP not confirmed by biopsy. Having considered the responses provided by the MAH
for Nexavar, the PRAC considered that the number of possible cases of AGEP with a temporal
relationship to sorafenib is very small and that the likelihood of a causal relationship between
treatment with sorafenib and AGEP is not sufficiently strong to warrant changes in the product
information at this stage. Nevertheless, the MAH should continue to monitor these events as part of
routine safety surveillance. Furthermore, the PRAC considered that the RMP should be updated at the
next regulatory opportunity to include a form to collect information on potential cases of AGEP, similar
to its approach for other severe cutaneous adverse reactions.
Summary of recommendation(s)
The MAH for Nexavar should continue to monitor cases of acute generalised exanthematous
pustulosis (AGEP) as part of routine safety surveillance. Furthermore, the MAH should update
the RMP at the next regulatory opportunity to include a form to collect information on potential
cases of AGEP, similar to its approach for other severe cutaneous adverse reactions.
5. Risk Management Plans
5.1. Medicines in the pre-authorisation phase
The PRAC provided advice to the CHMP on the proposed RMPs for a number of products (identified by
active substance below) that are under evaluation for initial marketing authorisation. Information on
the PRAC advice will be available in the European Public Assessment Reports (EPARs) to be published
at the end of the evaluation procedure.
Please refer to the CHMP pages for upcoming information
(http://www.ema.europa.eu/Committees>CHMP>Agendas, minutes and highlights).
5.1.1. Allogeneic cells genetically modified to express suicide gene
Evaluation of an RMP in the context of an initial marketing authorisation application procedure
Administrative details:
Product number(s): EMEA/H/C/002801, Orphan, ATMP
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 26/89