The Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China, has accepted a new drug application (NDA) from Everest Medicines for VELSIPITY (etrasimod), a treatment for adults with moderately to severely active ulcerative colitis (UC).
A once-daily oral medication, VELSIPITY is a sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4 and 5.
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The number of UC patients in China is projected to exceed one million by 2030, indicating a growing demand for innovative therapy options.
Everest is conducting a Phase III clinical trial across mainland China, Taiwan and South Korea.
The multicentre, double-blind, placebo-controlled study involves patients who have not adequately responded to standard therapies, including biologic and Janus kinase (JAinhibitor treatments.
Participants were administered 2mg etrasimod or a placebo over a 12-week induction phase.
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By GlobalDataEtrasimod demonstrated significant clinical improvements after 12 weeks across primary and secondary endpoints such as mucosal healing and symptomatic remission.
Etrasimod 2mg was well-tolerated and its safety profile was in line with previous studies with no new safety concerns reported.
Following the induction phase, responders were re-randomised to continue to receive etrasimod 2mg or placebo maintenance treatment for 40 weeks.
The results for this maintenance period are anticipated in the second half of 2024.
VELSIPITY’s efficacy as an oral treatment for ulcerative colitis has been recognised internationally, with approvals already in place from regulatory bodies in the US, the European Union and Canada through Pfizer, a licensing partner of Everest.
The company also sought approval for the therapy in Australia, India, Mexico, Russia, Singapore, Switzerland, Turkey and the UK.
Everest Medicines CEO Rogers Yongqing Luo stated: “We are pleased that the VELSIPITY NDA submission has now been accepted in Macau, which could become the first of our licensing territories in Asia to get approval.
“We also aim to take advantage of the preferential policies in the Greater Bay area to accelerate drug accessibility for mainland China.
“The company now awaits the 52-week data from our Phase 3 Asia clinical trial and plans to submit the NDA for NMPA [the National Medical Products Administration] approval in mainland China this year to benefit more Chinese patients as soon as possible.”
In November 2023, the company obtained approval from China’s NMPA for Nefecon to treat primary immunoglobulin A nephropathy (IgAN) in adults.
