PRAC meeting highlights from 14-17 May 2018

PRAC meeting highlights from 14-17 May 2018 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 recommendation – to suspend the marketing authorisations for HES solutions for infusion across the EU – 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 minimisation measures". 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/ news_and_events/news/2018/05/ news_detail_002954.jsp&mid=WC0b01ac058004d5c1 0114-9954/18/1704-0001/$14.95 Adis © 2018 Springer International Publishing AG. All rights reserved Reactions 2 Jun 2018 No. 1704 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Reactions Weekly Springer Journals

PRAC meeting highlights from 14-17 May 2018

Reactions Weekly , Volume 1704 (1) – Jun 2, 2018
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Publisher
Springer Journals
Copyright
Copyright © 2018 by Springer International Publishing AG, part of Springer Nature
Subject
Medicine & Public Health; Drug Safety and Pharmacovigilance; Pharmacology/Toxicology
ISSN
0114-9954
eISSN
1179-2051
D.O.I.
10.1007/s40278-018-46645-8
Publisher site
See Article on Publisher Site

Abstract

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 recommendation – to suspend the marketing authorisations for HES solutions for infusion across the EU – 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 minimisation measures". 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/ news_and_events/news/2018/05/ news_detail_002954.jsp&mid=WC0b01ac058004d5c1 0114-9954/18/1704-0001/$14.95 Adis © 2018 Springer International Publishing AG. All rights reserved Reactions 2 Jun 2018 No. 1704

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Reactions WeeklySpringer Journals

Published: Jun 2, 2018

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