Everest Medicines' VELSIPITY® (Etrasimod) Gains Regulatory Traction in Greater China for Ulcerative Colitis Treatment
核心洞察
Everest Medicines (搜索)' VELSIPITY® (etrasimod) NDA has been accepted in Hong Kong for treating moderately to severely active ulcerative colitis (搜索) in adults.
VELSIPITY® has already been approved in Macau and implemented in the Greater Bay Area via the 'Hong Kong and Macau Medicine and Equipment Connect' policy.
Clinical trials, including ELEVATE UC 52 and ELEVATE UC 12, support the efficacy and safety of etrasimod, showing significant clinical remission rates.
Everest Medicines (搜索) has announced significant progress in expanding the availability of VELSIPITY® (etrasimod) for the treatment of ulcerative colitis (搜索) (UC) in Greater China. The Department of Health of the Government of the Hong Kong Special Administrative Region, China, has accepted the New Drug Application (NDA) for VELSIPITY® for adult patients with moderately to severely active UC. This follows previous approvals in Macau and implementation in the Guangdong-Hong Kong-Macau Greater Bay Area through the "Hong Kong and Macau Medicine and Equipment Connect" policy.
Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines (搜索), stated, "Autoimmune disease is a core focus and a significant growth driver for our company. The number of UC patients in China is projected to double from 2019 to 2030 to approximately one million, highlighting the urgent need for novel treatments."
Clinical Evidence Supporting Efficacy
The acceptance of the NDA is based on results from the ELEVATE UC Phase 3 registrational program, encompassing the ELEVATE UC 52 and ELEVATE UC 12 trials. These studies evaluated the safety and efficacy of etrasimod 2 mg once-daily in achieving clinical remission in UC patients who had previously failed or were intolerant to conventional, biologic, or Janus kinase (搜索) (JAK) inhibitor therapies. Notably, nearly two-thirds of patients in these trials were naïve to biologic or JAK inhibitor therapy, and the studies included patients with isolated proctitis.
Both studies achieved all primary and key secondary efficacy endpoints, demonstrating a favorable safety profile consistent with previous studies of etrasimod. A multicenter, randomized, double-blind, and placebo-controlled Phase 3 trial of etrasimod in Asian countries, including mainland China, China Taiwan, and South Korea, further supports these findings. This trial, the largest of its kind in Asia for moderately-to-severely active UC, randomized 340 eligible subjects to treatment with etrasimod or placebo. Results from the induction period showed a clinical remission rate of 25.0% for patients treated with etrasimod 2mg, compared to 5.4% for those treated with placebo (difference 20.4%, p<0.0001).
VELSIPITY®: A Novel S1P Receptor Modulator
VELSIPITY® (etrasimod) is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor (搜索) subtypes 1, 4, and 5. It has already received regulatory approvals in the US, EU, Canada, Australia, Singapore, UK, Switzerland, Israel, and Macau for the treatment of ulcerative colitis (搜索).
Future Plans for Expanding Access
Everest Medicines (搜索) plans to submit an NDA for approval by China's National Medical Products Administration (NMPA) this year, with the aim of benefiting more Chinese patients as soon as possible. "This is an important advancement for etrasimod, bringing hope to patients in Hong Kong, China. This new-generation S1P receptor (搜索) modulator is an oral, once-daily treatment that can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief," said Prof. Wu Kaichun with the First Affiliated Hospital of AFMU, the principal investigator for etrasimod's Asia clinical trial.
With the number of UC patients in China projected to reach approximately one million by 2030, the potential approval of VELSIPITY® in mainland China could address a significant unmet medical need.