PML on Tecfidera – the MHRA response


Following the death due to PML last year of a German MSer who had been taking Tecfidera for over 4 years, and been lymphopenic for over 3, the MHRA has now issued a new “Drug safety update.

Your chances of developing an opportunistic infectious disease (such as PML in people who are JCV+) will increase if you have chronic lymphopenia.

The Barts-MS Guideline for people on Tecfidera is as follows:

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  • I would reckon similar guidelines shall apply to fingolimod , I had 2.95 *10^9 WBC and 0.59 *10^9 Lympho in the last blood test one year post initiation of therapy …

  • Seems that the regulators must have some significant concerns on the safety profile of Tecfidera given that they are asking Biogen idec to conduct further safety studies into PML associated with Tecfidera as noted below:

    Based on the evidence available so far it was recommended that PML should be added to the RMP as a separate important identified risk. In addition, the PRAC recommended requesting a joint study as part of the obligation of the marketing authorisations for Tecfidera and Fumaderm to further characterise effects on lymphocyte subsets and to explore their clinical relevance with the objective of further evaluation of the mechanism underlying lymphopenia, frequency and pattern of lymphopenia and PML, timeframe of reversibility/recovery of lymphopenia, and risk factors predisposing patients for lymphopenia and development of PML.

    A draft synopsis including proposals for sample size, feasibility, interim analyses, and timelines should be provided.

    In addition, the PRAC recommended mechanistic studies to obtain further insight into the characterisation of cellular and molecular/signalling targets for dimethyl fumarate. Moreover, the PRAC suggested disseminating a further DHPC (in addition to that in December 2014 following the signal assessment, see PRAC minutes November 2014) as a further risk minimisation measure. The MAH advised to request the MAH to submit a DHPC to be reviewed in line with the wording for inclusion in the product information as agreed by the CHMP. The PRAC also recommended obtaining further expert advice of the Scientific Advisory Group (SAG) Neurology in relation to risk minimisation measures.

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