Another PCSK9 inhibitor is amoros Buzumab (trade name: Praluent) from Sanofi.
/kloc-in September/February, Sanofi /Regeneron announced that FDA had accepted the application for biological product supplement (sBLA) of its PCSK9 monoclonal antibody Praluent (alirocumab, Alicu monoclonal antibody).
The sBLA submitted by Sanofi /Regeneron is based on the data of the third ODYSSEYOUTCOMES study, aiming at updating the prescription information of Praluent and increasing the indication that Praluent can reduce the overall risk of major cardiovascular adverse events (MACE). The scheduled approval time of PDUFA is 2065438+April 28th, 2009.
Article source: Medical Rubik's Cube website WeChat official account
Two companies are competing for the patent of PCSK9 inhibitor:
20 14, 10 In June, Amgen sued Sanofi and Regeneron for patent infringement in Delaware District Court, claiming that the monoclonal antibody alirocumab produced by Amgen infringed on three American patents of Amgen on PCK9 monoclonal antibodies (patent number: 8563698, 8829 165,
Article link: Please see the news that two companies are suing for PCSK9 inhibitors.