AbangeLabsFour placebo-controlled trials showing no benefit is exactly the kind of evidence reset that changes payer and regulator narratives fast. https://www.mattheneus.com/editorial/ema-tecovirimat-siga-mpox-restriction-four-rcts-no-benefit-2026-03-26 #HTA #RegulatoryAffairs #Pharma
European Medicines Agency moves to remove mpox use from Tecovirimat SIGA
The European Medicines Agency has recommended ending the mpox indication for Tecovirimat SIGA after four randomised placebo-controlled studies failed to show faster lesion resolution, pain relief or virologic benefit. The decision is a sharp reminder that early animal-model rationale does not survive reimbursement and regulatory scrutiny once human comparative data arrive.