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Parliamentary questions
PDF 105kWORD 19k
20 October 2017
E-005241/2017(ASW)
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-005241/2017

The Commission has indeed granted marketing authorisations to several new medicines to be taken orally rather than by injection(1), including a dimethyl fumarate-containing medicinal product for the treatment of psoriasis.

The scientific evaluation of marketing authorisation applications for EU centrally authorised medicinal products is performed by the European Medicines Agency (EMA). EMA’s opinions are based on assessment of all available evidence and approval is recommended when the desired effects or ‘benefits’ of a medicine outweigh its undesired effects or ‘risks’. This is the case for the abovementioned product. The European public assessment reports, which contain all the information about the evaluated scientific evidence, are published on the website of the EMA(2).

With regard to the dimethyl fumarate-containing product to treat psoriasis and possible occurrence of hepatotoxicity, Skilarence’s Summary of product characteristics (SmPC) notes that the medicinal product must not be used in patients who have severe problems of the digestive system, liver or kidneys(3). The SmPC of Tecfidera states the product ‘has not been studied in patients with severe renal or severe hepatic impairment and caution should, therefore, be used in these patients’; Tecfidera’s Package Leaflet warns patients to talk to their doctor before taking it if they have severe liver disease(4). Aubagio’s SmPC and Package Leaflet state that it must not be used in patients with severe liver disease(5).

(1)dimethyl fumarate-containing medicinal products Tecfidera (2014, for multiple sclerosis) and Skilarence (2017, for psoriasis), teriflunomide-containing Aubagio (2013, for multiple sclerosis) and leflunomide-containing products (from 1999, for rheumatoid and psoriatic arthritis).
(2)http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d125/
(3)http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002157/human_med_002118.jsp&mid=WC0b01ac058001d124
(4)http://ec.europa.eu/health/documents/community-register/2017/20170412137698/anx_137698_en.pdf
(5)http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002514/WC500148682.pdf

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