Everest Medicines’ New Drug Application for VELSIPITY® Accepted in Hong Kong
Monday, December 02, 2024
Everest Medicines has announced the acceptance of its New Drug Application (NDA) for VELSIPITY® (etrasimod) by the Department of Health of the Hong Kong Special Administrative Region.
VELSIPITY® is a once-daily oral treatment classified as a sphingosine 1-phosphate (S1P) receptor modulator, targeting S1P receptor subtypes 1, 4, and 5. It is designed to provide effective management for moderately to severely active ulcerative colitis, offering a potential corticosteroid-free remission option for patients.
The submission covers the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
VELSIPITY®, an oral, once-daily therapy, has already been approved in several markets, including the United States, European Union, and Macau, through Everest's licensing partner, Pfizer.
Earlier this year, the drug received approval in Macau and was implemented in the Guangdong-Hong Kong-Macau Greater Bay Area under the “Hong Kong and Macau Medicine and Equipment Connect” policy.
The NDA acceptance is supported by data from the ELEVATE UC Phase 3 trials, which assessed the safety and efficacy of etrasimod in UC patients who had previously failed or were intolerant to conventional, biologic, or Janus kinase (JAK) inhibitor therapies.
The studies achieved their primary and key secondary endpoints, demonstrating significant clinical remission and mucosal healing rates, along with a favourable safety profile.
A multicentre, randomised, double-blind, placebo-controlled Phase 3 trial conducted by Everest in Asian countries, including mainland China, Taiwan, and South Korea, marked the largest study of its kind in the region for UC. The trial involved 340 eligible participants, with the results highlighting the significant clinical benefits of etrasimod over placebo.
The induction period showed a clinical remission rate of 25% for the etrasimod group compared to 5.4% for placebo, while maintenance period outcomes confirmed sustained efficacy over 40 weeks of treatment.
Etrasimod has been approved for use in UC in several countries, including the United States, European Union, Canada, Australia, and Singapore, among others. Everest Medicines plans to further expand access by submitting additional regulatory applications in China and other regions.
Source: everestmedicines.com
