Everest Medicines, a prominent biopharmaceutical firm dedicated to pioneering drug discovery, clinical progress, production, and bringing novel treatments to market, announced the Hong Kong Special Administrative Region’s Department of Health has accepted their New Drug Application (NDA) for Velsipity (etrasimod). This treatment is intended for adult patients suffering from moderate to severe active ulcerative colitis.
Velsipity offers a once-daily, oral regimen for individuals with moderate-to-severe UC. This treatment has already received approval across the United States, European Union, and additional nations by Everest’s collaborator, Pfizer. In regions managed by Everest, Macau’s Pharmaceutical Administration endorsed Velsipity’s NDA in April, with the medication rolled out in the Guangdong-Hong Kong-Macau Greater Bay Area this October via the “Hong Kong and Macau Medicine and Equipment Connect” initiative.
“Our primary focus is autoimmune diseases, a critical growth area for us. Projections indicate a doubling of UC cases in China by 2030, reaching close to a million, underlining the need for innovative solutions,” stated Rogers Yongqing Luo, Everest Medicines’ CEO. “Velsipity is already recognized in Macau, with implementation underway in the Greater Bay Area through the connect system. Plans are set to present NDA to China’s National Medical Products Administration (NMPA) this year, enhancing benefits for Chinese patients soon.”
“This marks a pivotal step forward for etrasimod, providing a ray of hope for patients in Hong Kong. This new S1P receptor modulator offers an oral, daily treatment potential that assures corticosteroid-free remission, mucosal recovery, and swift symptom relief,” commented Prof. Wu Kaichun from the First Affiliated Hospital of AFMU, leading etrasimod’s clinical trials in Asia. “We anticipate quick approvals across China and other Asian territories to aid more patients.”
The nod for the NDA stemmed from the ELEVATE UC Phase 3 registration studies (ELEVATE UC 52 and ELEVATE UC 12), which evaluated a 2 mg daily dose of etrasimod for clinical remission in UC patients with moderate to severe symptoms who had previously failed to respond or couldn’t tolerate at least one conventional, biologic, or Janus kinase (JAK) inhibitor treatment. Notably, almost two-thirds of participants in ELEVATE UC 52 and ELEVATE UC 12 hadn’t received biologic or JAK treatments before, making these the only studies for advanced UC therapies to encompass isolated proctitis patients. All key and primary efficacy targets were met in these studies, showcasing a safety profile aligned with former etrasimod research.
Everest embarked on a multicountry, double-blind, placebo-controlled Phase 3 trial of etrasimod across Asia, including mainland China, Taiwan, and South Korea. It stands as the largest of its kind in Asia for this condition, enrolling 340 participants to receive either etrasimod or placebo.
Initial findings from the induction phase revealed a 25% remission rate for those on 2mg etrasimod compared to 5.4% on placebo (difference 20.4%, p<0.0001). Etrasimod recipients also exhibited significant clinical and statistical enhancements in all essential secondary endpoints.
Topline outcomes from the maintenance phase, disclosed in July, confirmed that 40 weeks of etrasimod therapy signified pronounced clinical and statistical gains over placebo for both key primary and secondary endpoints (p<0.0001), including mucosal healing and endoscopic normalization (both p<0.0001).
The etrasimod safety profile was consistent with prior investigations, with no new safety concerns noted. Maintenance period findings will be shared at an international scientific symposium.
Velsipity, characterized as a once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator targeting S1P receptor subtypes 1, 4, and 5, has received regulatory approvals in the US, EU, Canada, Australia, Singapore, UK, Switzerland, Israel, and Macau, China for UC management.
Everest Medicines remains committed to discovering, developing, and commercializing transformative drugs and vaccines that significantly meet unmet medical demands in Asian societies.