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  • Re-evaluation possibility of 'Bylvay' gathers attention
  • by Eo, Yun-Ho | translator Hong, Ji Yeon | May 26, 2025 05:57am
The 1st drug selected for the approval-eval-negotiation pilot project¡¦Bylvay did not pass the DREC review held in April
The Phase 3 ASSERT study showed a significant improvement in itchiness
 ¡ã Product photo of Ipsen Korea
Attention has been drawn to when 'Bylvay Cap,' the first medicine chosen for the 'Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations,' will be re-evaluated.

Bylvay (odevixibat), Ipsen Korea's treatment option for progressive familial intrahepatic cholestasis (PFIC) in patients aged 3 months or older, received a decision of reevaluation at the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Evaluation Committee (DREC) meeting held in April.

After that, the drug had not been considered for the DREC review in May so it will likely be considered for the upcoming review.

As part of implementing the first concurrent approval-ev
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