Regeneron Says EMA Panel Recommends Approval of Updated Dosing Regimen for Libtayo

MT Newswires Live10-16 19:34

Regeneron Pharmaceuticals (REGN) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of an updated dosing schedule for Libtayo across all approved indications in the European Union.

The recommendation supports 30-minute intravenous therapy with Libtayo 700 milligrams every six weeks following an initial 12 weeks of treatment with 350 mg every three weeks, the company said.

The panel also recommended an option to shorten the infusion time for the 350 mg dose to 15 to 30 minutes, provided the first infusion, administered over 30 minutes, was well tolerated, according to Regeneron.

The European Commission is expected to issue its final decision in the coming months, the company said.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap
Leave a comment