Sanofi and Regeneron withdraw license application for Libtayo in the United States | Photo credits: (c) Sanofi Pasteur
PARIS (Agefi-Dow Jones)–The pharmaceutical group Sanofi and the biotechnology company Regeneron announced on Friday the withdrawal of a request for a supplemental biological product license (Biologics License Application, BLA) for their drug Libtayo as a treatment for second line for people with advanced cervical cancer.
The two groups said they had made this decision voluntarily after failing to agree with the Food and Drug Administration (FDA), the American health authority, on certain post-marketing studies. “Discussions with regulatory authorities outside the United States are continuing,” the two companies said.
Libtayo is developed and marketed by Regeneron and Sanofi under a global collaboration agreement.
-Julien Marion, Agefi-Dow Jones; +33 (0)1 41 27 47 94; [email protected] ed: VLV
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January 28, 2022 07:58 ET (12:58 GMT)