Regeneron seeks six-week Libtayo dosing across EU indications

• Regeneron announced that the European Medicines Agency's CHMP recommended an alternative Libtayo dosing schedule across all six EU-approved indications.
• The proposed regimen allows 700 mg every six weeks after 12 weeks of treatment at 350 mg every three weeks, potentially reducing infusion appointment frequency.
• Regeneron expects a European Commission decision in the coming months, while the six-week schedule is already authorized for one existing skin cancer indication.

Regeneron Pharmaceuticals (NASDAQ:REGN) announced a positive European regulatory recommendation allowing Libtayo dosing every six weeks across six approved cancer indications, subject to final authorization.

The proposed extension follows existing European approval of the six-week regimen for adults with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.

The CHMP recommended administering 700 mg of Libtayo every six weeks through a 30-minute intravenous infusion after an initial 12 weeks of 350 mg every three weeks.

The recommendation also permits 15- to 30-minute infusions for the 350 mg dose when patients have tolerated their first 30-minute infusion, potentially reducing time spent receiving treatment.

Regeneron expects a European Commission decision in the coming months, while its shares last closed up 2.31% at $796.34 on October 15, before a confirmed post-announcement market reaction was available.

Libtayo, also known as cemiplimab, is an immunotherapy targeting the PD-1 pathway, which helps cancer cells evade immune responses, and is used for several skin, lung and cervical cancers.

Regeneron previously secured European authorization for Libtayo in high-risk cutaneous squamous cell carcinoma, supported by its Phase 3 C-POST trial, which reported a 68% reduction in recurrence or death risk compared with placebo.