Everest Medicines (HKG: 1952), based in China, has announced that its New Drug Application (NDA) for Velsipity (etrasimod) for the treatment of moderate-to-severe active ulcerative colitis (UC) has been accepted for review by the regulatory authority in Macau. This marks Macau as the first region in Asia, within Everest’s licensed territory, poised to approve the drug. The anticipated approval is expected to facilitate access to Velsipity in mainland China, aided by the Greater Bay Area policies.
Velsipity is a once-daily oral sphingosine 1-phosphate (S1P) receptor modulator that selectively targets S1P receptor subtypes 1, 4, and 5. The drug received approval in the United States for moderate-to-severe UC in October 2022, followed by marketing authorization in the European Union in February 2023. Regulatory submissions for Velsipity in UC have also been made in multiple markets, including Canada, Australia, Mexico, Russia, Switzerland, and Singapore. Everest secured development rights for Velsipity in Greater China and South Korea through a licensing agreement with Arena Pharmaceuticals, a subsidiary of Pfizer, in 2017.- Flcube.com
