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Everest's New Drug Application For VELSIPITY® Accpected, Advances UC Treatment in Hong Kong

Everest Medicines' NDA for VELSIPITY® (etrasimod), a once-daily oral UC treatment, has been accepted by Hong Kong's Department of Health.

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  • Dec 02, 2024

  • Simantini Singh Deo

Everest's New Drug Application For VELSIPITY® Accpected, Advances UC Treatment in Hong Kong

Everest Medicines, a biopharmaceutical company specialising in innovative therapies, announced that the Department of Health of Hong Kong has accepted its New Drug Application (NDA) for VELSIPITY® (etrasimod). This once-a-day oral treatment is designed for adult patients with moderately to severely active ulcerative colitis (UC). VELSIPITY® has previously received approval in the United States, European Union, and other regions through Everest's licensing partner, Pfizer. In April, the drug was approved in Macau, and its use was extended to the Guangdong-Hong Kong-Macau Greater Bay Area in October under the "Hong Kong and Macau Medicine and Equipment Connect" policy.

Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, said, "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. Previously, VELSIPITY® was approved in Macau, China, and implemented in the Greater Bay Area through the connected policy. The company also plans to submit the NDA for approval by China’s National Medical Products Administration (NMPA) this year, intending to benefit more Chinese patients as soon as possible."

The NDA acceptance is supported by findings from the Phase 3 ELEVATE UC program (ELEVATE UC 52 and ELEVATE UC 12), which supported the safety and efficacy of etrasimod in UC patients who could not tolerate traditional treatments, biologics, or Janus Kinase (JAK) inhibitors. The studies included patients with isolated proctitis and enrolled many individuals new to advanced therapies like biologics or JAK inhibitors. Both trials met all primary and secondary endpoints, showing significant efficacy and a favourable safety profile consistent with prior studies.

Prof. Wu Kaichun with the First Affiliated Hospital of AFMU, the principal investigator for Etrasimod’s Asia clinical trial, said in a statement, "This is an important advancement for etrasimod, bringing hope to patients in Hong Kong, China. This new-generation S1P receptor modulator is an oral, once-daily treatment that can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief. We hope China and other Asian countries can obtain approvals soon to benefit more patients."

Everest also conducted an intense Phase 3 trial in Asia, including China, Taiwan, and South Korea, involving 340 participants with moderately to severely active UC. The study's induction period demonstrated that 25% of patients treated with etrasimod achieved clinical remission compared to 5.4% in the placebo group, a statistically significant improvement (p<0.0001). Additionally, etrasimod significantly overcame the placebo on all critical secondary endpoints. The maintenance phase further confirmed these results, showing sustained efficacy and a strong safety profile after 40 weeks. Detailed findings from the maintenance phase will be presented at an upcoming international academic conference.

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