Reactions 1704, p2 - 2 Jun 2018
PRAC meeting highlights from
14-17 May 2018
Two reviews for ulipristal and daclizumab are now
complete, and the PRAC
confirms its recommendation
for hydroxyethyl starch (HES) solutions for infusion,
says the EMA.
At its recent May meeting, the PRAC confirmed its
previous conclusion about the multiple sclerosis
medicine daclizumab (Zinbryta)
that the risks of this
medicine (i.e. serious and potentially fatal immune
reactions affecting the brain, liver and other organs)
outweigh its benefits in patients with multiple sclerosis.
The European Commission (EC) withdrew the
marketing authorisation for Zinbryta on 27 March this
year, following a request from Biogen Idec (i.e.
authorisation holder). "However, there are no immediate
consequences of the PRAC’s review as Zinbryta is no
longer authorised in the EU", noted the EMA.
In addition, the PRAC has completed a review of
ulipristal (Esmya) following reports of serious liver
injury, and concluded that this medicine "must not be
used in women with liver problems and that certain
other patients may start new treatment courses provided
they have regular liver tests".
Also, PRAC has recommended that women who are
not eligible for surgery should use more than one course
of Esmya. Women who are about to have surgery should
continue to use only one course.
Finally, the PRAC has confirmed that its previous
to suspend the marketing
authorisations for HES solutions for infusion across the
remains valid. This decision came after the EC
requested the PRAC to consider whether suspending the
marketing authorisations for HES solutions "could result
in an unmet medical need", noted the EMA. The agency
added that the EC also requested the PRAC to "consider
the feasibility and likely effectiveness of additional risk
The PRAC’s recommendation will now be sent to the
regulatory body, CMDh.
, for consideration at its
upcoming meeting (28-30 May).
* PRAC = Pharmacovigilance Risk Assessment Committee
** CMDh = Co-ordination Group for Mutual Recognition and
Decentralised Procedures - Human.
European Medicines Agency. Meeting highlights from the Pharmacovigilance Risk
Assessment Committee (PRAC) 14-17 May 2018. Internet Document : 18 May
2018. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/
Reactions 2 Jun 2018 No. 17040114-9954/18/1704-0001/$14.95 Adis © 2018 Springer International Publishing AG. All rights reserved