Health Department approves VELSIPITY for severe ulcers

The number of UC patients in China is projected to double by 2030.

The Department of Health has approved using VELSIPITY(R) to treat adult patients with moderately to severely active ulcerative colitis (UC).

VELSIPITY developer, Everest Medicines, said the drug has been approved in the United States, European Union, and other countries, by Everest’s licensing partner, Pfizer.

In Everest territories, China approved the VELSIPITY(R) application in April of this year, and was implemented in the Guangdong-Hong Kong-Macau Greater Bay Area in October.

"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," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines.

The acceptance of the NDA was based on results from the ELEVATE UC Phase 3 registrational program that evaluated the safety and efficacy of etrasimod 2 mg once-daily on clinical remission in UC patients with moderately to severely active UC.

The results of the induction period indicate that the clinical remission rate for patients treated with etrasimod 2mg was 25%, compared to 5.4% for those treated with a placebo.

Moreover, the results from the maintenance period released last July confirmed that after 40 weeks of treatment, etrasimod demonstrated significant clinical and statistical improvements over placebo in the primary and all key secondary endpoints.