Libtayo is an anti-cancer drug developed by Regeneron Pharmaceuticals Inc. and Sanofi for advanced cervical cancer patients. The two companies withdrew their application for expanded use with the U.S. drug regulator.
In a statement on Friday, the companies said that their application to use monoclonal antibodies for treatment in second-line patients was withdrawn “because the companies and the FDA could not align on certain post-marketing studies”.
Priority review of the supplemental application had been accepted by the FDA in September.
According to the company, Regeneron and Sanofi are in discussions with regulatory authorities outside the United States regarding marketing applications.
The drug is already approved for the treatment of certain types of skin and lung cancers.
For the third quarter, Regeneron sold Libtayo for $78 million, while Sanofi made $35 million euros ($38.98 million).
($1 = 0.8978 euros)