Regeneron Pharma Says EMA’s CHMP Adopts Positive Opinion Recommending Approval Of Alternative Dosing Schedule For Libtayo Across All Approved Indications

Regeneron Pharmaceuticals announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending an alternative dosing schedule for Libtayo (cemiplimab). The recommendation supports reducing the dosing frequency from every three weeks to every six weeks after an initial 12-week treatment, along with an optional reduction of infusion time for the 350 mg dose. The final decision from the European Commission is expected in the coming months, which would allow this regimen across all six approved indications in the EU.