Everest Medicines’ VELSIPITY® NDA accepted in Taiwan for ulcerative colitis

TAIWAN—Everest Medicines has announced a significant milestone as the Taiwan Food and Drug Administration (TFDA) officially accepted the New Drug Application (NDA) for VELSIPITY® (etrasimod).

This drug targets patients with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease.

This acceptance follows shortly after the TFDA approved a supplementary application for Everest’s drug NEFECON®, further reflecting the company’s growing presence in the Taiwanese pharmaceutical market.

VESLIPITY® is a next-generation, selective sphingosine 1-phosphate (S1P) receptor modulator, administered orally once daily.

It has shown strong effectiveness across several important treatment goals for UC, including clinical remission, mucosal healing, endoscopic normalization, and histological remission.

These benefits have been backed by multiple global Phase III clinical trials, such as ELEVATE UC 52, ELEVATE UC 12, and the ENLIGHT (ES101002) study.

This latest approval in Taiwan represents another step forward in Everest Medicines’ efforts to commercialize VELSIPITY® throughout Asia.

The drug has already gained approvals in Singapore, Hong Kong SAR, and Macao SAR, and its NDA has been accepted in South Korea.

Moreover, China’s National Medical Products Administration (NMPA) accepted the NDA for VELSIPITY® in December 2024.

Rogers Yongqing Luo, CEO of Everest Medicines, commented on the acceptance, emphasizing its importance in expanding access to this innovative treatment across Asia.

He highlighted the rising number of UC patients in the region, noting that in China alone, approximately 800,000 people lived with ulcerative colitis in 2024. This figure is projected to reach 1 million by 2030.

Luo pointed out that UC patients face ongoing challenges in managing their disease and maintaining a good quality of life.

He affirmed that the NDA approval reinforces the clinical value of VELSIPITY® and committed to accelerating its availability in Mainland China and other Asian markets to support long-term disease management.

The data submitted to the TFDA mainly came from the ELEVATE UC Phase 3 trials and the ENLIGHT study.

The ELEVATE UC program tested etrasimod’s safety and effectiveness in patients who had moderately to severely active UC and had not responded well to at least one conventional, biologic, or Janus kinase (JAK) inhibitor treatment.

Both studies successfully met their primary and key secondary endpoints and showed a favorable safety profile consistent with earlier findings.

The ENLIGHT study, a large Phase 3 trial conducted across Asian countries including Mainland China, Taiwan, and South Korea, enrolled 340 eligible patients with moderate to severe UC.

It demonstrated that daily treatment with 2 mg of etrasimod produced significant improvements in all primary and secondary efficacy measures compared to placebo.

 These results provide strong support for the use of VELSIPITY® in Asian adults suffering from this challenging condition.

As Everest’s third commercialized product, VELSIPITY® has received official approval from the Guangdong Provincial Medical Products Administration for adult patients with moderately to severely active UC.

It is now accessible at medical centers designated under the Connect Policy in the Greater Bay Area.

To further support local supply, Everest is also constructing a manufacturing facility at its Jiashan site, which will help sustain production and meet future demand.

Sign up HERE to receive our email newsletters with the latest news and insights from Africa and beyond. Also, follow us on our WhatsApp channel for updates.