WASHINGTON (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of an alternative dosing schedule for Libtayo (cemiplimab) across all approved indications.
The pharmaceutical company develops treatments for serious medical conditions. The CHMP's recommendation supports an extended dosing regimen of higher-dose Libtayo at 700 mg administered as a 30-minute intravenous infusion every six weeks, following an initial 12-week regimen of Libtayo 350 mg administered as a 30-minute intravenous infusion every three weeks.
The positive opinion also supports a 15- to 30-minute infusion option for patients receiving Libtayo 350 mg every three weeks, if their first infusion at this dose level was well tolerated when administered over 30 minutes. This option could reduce treatment time by up to half.
The positive CHMP opinion is supported by comprehensive pharmacokinetic and pharmacodynamic modeling and simulation data, integrated with clinical safety and efficacy data from Libtayo's clinical development program.
The European Commission (EC) is expected to make a final decision on the application in the coming months, which would allow this dosing regimen to be applied across all six approved indications in the European Union (EU).
The Libtayo 700 mg every six-week dosing option is already approved in the EU for use after an initial 12 weeks as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.
Across all other approved indications, an alternative dosing regimen remains available, including Libtayo 350 mg every three weeks administered as an intravenous infusion over 30 minutes.
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