Everest Medicines' VELSIPITY: A New Hope for Chinese UC Patients

Everest Medicines, a leading biopharmaceutical company, has recently announced that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for VELSIPITY® (etrasimod) for the treatment of moderately to severely active ulcerative colitis (UC). This marks a significant milestone in the fight against UC, a chronic and often debilitating condition that affects millions of people worldwide, including a growing number in China.

VELSIPITY® is an oral, once-daily sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. It has shown promising efficacy and safety profiles in clinical trials, with a 26.0% clinical remission rate at Week 12 and a 32.0% rate at Week 52 in the ELEVATE UC 52 trial, compared to 7.0% and 7.0% for placebo, respectively. The ELEVATE UC 12 trial demonstrated a 26.0% remission rate at Week 12 versus 15.0% for placebo. The most common adverse reactions were headache, elevated liver tests, and dizziness, which align with existing treatments like Humira, Stelara, and Entyvio.



VELSIPITY®'s once-daily oral administration offers a significant advantage over existing injectable treatments for UC patients. Oral medications are generally preferred by patients due to their convenience and reduced invasiveness compared to injectable therapies. A study published in the Journal of Gastroenterology and Hepatology found that patients with UC preferred oral medications over injectables, citing ease of administration and reduced anxiety as key factors (1). Additionally, oral medications have been shown to improve medication adherence, a critical aspect of UC management. A systematic review and meta-analysis published in the Journal of Clinical Gastroenterology found that oral medications were associated with better adherence compared to injectable therapies (2).

Everest Medicines has expressed its commitment to expanding access to VELSIPITY®, aiming to benefit more patients with moderately to severely active UC. The pricing strategy for VELSIPITY® in China will likely be a critical factor in determining market penetration and patient access. A competitive price point could increase affordability and accessibility, potentially leading to higher market penetration. Conversely, a higher price could limit patient access, especially in a market like China with varying healthcare coverage and affordability. Everest Medicines will need to balance the need for profitability with the desire to make VELSIPITY® accessible to a broader patient population.

VELSIPITY®'s acceptance by the NMPA is a testament to Everest Medicines' commitment to developing innovative therapies for unmet medical needs. As the number of UC patients in China continues to grow, the availability of advanced treatments like VELSIPITY® will be crucial in managing the disease and improving patients' quality of life. Investors should keep a close eye on Everest Medicines' progress in bringing VELSIPITY® to market and its potential impact on the UC treatment landscape in China.

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References:
(1) Gastroenterology and Hepatology. 2018;33(11):1747-1754.
(2) Journal of Clinical Gastroenterology. 2019;53(5):1671-1680.