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NICE update on Eteplirsen
May 11, 2018 by abzali123
Following last week’s announcement that Sarepta’s exon skipping drug, Eteplirsen,had received a negative trend vote from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
The company has been in touch with the National Institute for Health and Care Excellence (NICE),to inform them of the anticipated delayed regulatory timings.As you know, NICE had scheduled to evaluate eteplirsen under their Highly Specialised Technology (HST) program this Summer.
The forthcoming submission deadline on 17 May 2018 and forthcoming committee discussion on 23 August 2018, will be revised for HST evaluation. NICE hope to communicate the revised submission deadline and first committee discussion date by mid-June 2018 to the stakeholders,including the UK patient organisations involved in the appraisal process.
We understand and feel the Duchenne communities’ frustration at the delays. We wish to thank all those who have shared their personal perspectives and journey’s to date and we will continue to work with our charity partners in the UK and Internationally to continue to ensure your voices are heard and address the challenges faced ahead together.
If you have any questions, we would be delighted to hear from you, please feel free to get in touch with our Director of Research, Neil Bennett neil@actionduchenne.org or reach us at Head Office on 020 7250 8240.