Vanda Completes Transfer of FDA Marketing Authorization for PONVORY

 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that ownership of the U.S. New Drug Application and Investigational New Drug Applications for PONVORY® (ponesimod) has been transferred to Vanda from a Johnson & Johnson Company, which now fully allows Vanda to commercialize PONVORY® in the U.S.

"This milestone completes the transfer of the FDA marketing authorization to Vanda and allows Vanda to commence full commercialization efforts and begin clinical development programs as we seek to maximize the potential of Ponvory in the treatment of a host of inflammatory disorders," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board.

Vanda acquired U.S. and Canadian rights to PONVORY® from a Johnson & Johnson Company on December 7, 2023. PONVORY® is approved by the U.S. Food and Drug Administration (FDA) and Health Canada to treat adults with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease (RMS).

In anticipation of the commercial launch of PONVORY® for RMS in the third quarter of 2024, Vanda is initiating a host of commercial activities including the creation of a specialty sales force, a prescriber awareness program and a comprehensive marketing program.

https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-completion-of-transfer-of-fda-marketing-authorization-for-ponvory-302160024.html