EMA advisory committee backs extended dosing schedule for Regeneron's Libtayo
Regeneron announced that the European Medicines Agency’s advisory committee for medicinal products issued a positive opinion on a new dosing regimen for Libtayo (cemiplimab). The proposal calls for patients to receive 350 mg every three weeks for the first 12 weeks, then switch to a 700 mg dose given every six weeks as a 30‑minute infusion. The committee also suggested that, for patients whose initial 30‑minute infusion of the 350 mg dose is well tolerated, subsequent infusions could be shortened to 15‑30 minutes. The European Commission must give final approval in the coming months.
Why it matters
Regulators note that the less‑frequent schedule could cut hospital visits and lower administration costs, which may improve the drug’s market appeal in Europe (the company says). However, until the Commission signs off, the change cannot affect sales or pricing.
Key facts
- 1The EMA advisory committee issued a positive opinion recommending a 350 mg dose every three weeks for 12 weeks followed by a 700 mg dose every six weeks as a 30‑minute infusion. stocktitan.net
- 2The opinion also allows the 350 mg infusion time to be reduced to 15‑30 minutes if the first 30‑minute infusion is well tolerated. stocktitan.net
- 3The European Commission will decide on the recommendation in the next few months. rttnews.com
- 4Regeneron’s shares closed at $769.34, up 2.31% after the announcement. rttnews.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.