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news.The Department of Health of the Hong Kong Special Administrative Region, China, has accepted the new drug application (NDA) for oral VELSIPITY (etrasimod) submitted by Everest Medicines, for treating adults with moderately to severely active ulcerative colitis (UC).
The therapy is intended to treat moderately to severely active ulcerative colitis in adult individuals. Credit: Volodymyr Hryshchenko on Unsplash.
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VELSIPITY already secured approvals in the European Union, the US, and other countries through Everest’s licensing partner, Pfizer.
The acceptance was grounded on data from the ELEVATE UC Phase III registrational programme, which involved ELEVATE UC 52 and ELEVATE UC 12 studies.
These studies assessed the efficacy and safety of once daily etrasimod 2mg dose in achieving clinical remission in UC subjects who had not responded to or could not tolerate biologic, Janus kinase (JAK) inhibitors or conventional therapies.
They met all primary and key secondary efficacy endpoints, showcasing a safety profile in line with prior studies of etrasimod.
Everest also carried out a randomised, multicentre, placebo-controlled, and double-blind Phase III trial in Asian countries, including mainland China, China Taiwan, and South Korea.
This trial included 340 patients who were randomised to receive either the therapy or a placebo.
The induction period outcomes revealed a clinical remission rate of 25.0% in the etrasimod-treated group, significantly higher than the 5.4% observed in the placebo group.
In the territories covered by Everest, the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China, approved the VELSIPITY NDA in April 2024, with its implementation in the Guangdong-Hong Kong-Macau Greater Bay Area in October. The policy known as “Hong Kong and Macau Medicine and Equipment Connect” facilitated this rollout.
Everest Medicines CEO Rogers Yongqing Luo 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 has already been approved in Macau, China, and was implemented in the Greater Bay Area through the connect policy.
“The company also plans to submit the 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.”
