Everest Medicines' Licensing Partner Pfizer Announces FDA and EMA Acceptance of Etrasimod Regulatory Submissions for Ulcerative Colitis
SHANGHAI,Dec. 22,2022 -- Everest Medicines (HKEX 1952.HK) announced today that its licensing partner,Pfizer Inc. (NYSE: PFE) has received acceptance from the U.S. Food and Drug Administration (FDA) for review a New Drug Application (NDA) for etrasimod for individuals living with moderately-to-severely active ulcerative colitis (UC). The FDA's decision is expected in the second half of 2023. The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for etrasimod in the same patient population with the decision anticipated in the first half of 2024. The anticipated U.S. FDA approval will be the first approval of etrasimod globally.
"We congratulate our partner for making important regulatory advancements towards bringing etrasimod as a potentially best-in-class therapy to ulcerative colitis patients," said Rogers Yongqing Luo,Chief Executive Officer of Everest Medicines. "We aim to complete patient enrollment for our phase 3 study in Asia in the first half of 2023 and,if approved,hope to bring this novel treatment to Asian population as soon as possible."
Etrasimod was developed by Arena Pharmaceuticals,which was acquired by Pfizer earlier this year. Everest Medicines obtained exclusive rights from Arena to develop,manufacture and commercialize etrasimod in Greater China and South Korea in 2017. The incidence of UC is increasing continuously in China in the recent decades. The number of UC patients in China is expected to more than double from 2019 to reach over 900,000 by 2030 highlighting significant unmet demand for novel treatment for the disease. According to the Frost & Sullivan report,the market size of UC was RMB3.4 billion in 2019 in China and is estimated to expand to RMB8.1 billion by 2024,representing compound annual growth rate of 18.9%.
Pfizer's NDA submissions were based on previously announced results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) that evaluated the safety and efficacy of etrasimod 2 mg once daily on clinical remission in UC patients who had previously failed or were intolerant to at least one conventional,biologic,or Janus kinase (JAK) inhibitor therapy. Both randomized,double-blind,placebo-controlled studies achieved all primary and key secondary endpoints,with a safety profile consistent with previous studies. In the ELEVATE UC 52 study,clinical remission was 27.0% for patients receiving etrasimod compared to 7.4% for patients receiving placebo at week 12 (19.8% differential,P≤.001) and was 32.1% compared to 6.7% at week 52 (25.4% differential,P≤.001). In ELEVATE UC 12,clinical remission was achieved among 24.8% of patients receiving etrasimod compared to 15.2% of patients receiving placebo (9.7% differential,P=.0264).
About Etrasimod
Etrasimod is an oral,once-a-day,selective sphingosine 1-phosphate (S1P) receptor modulator designed for optimized pharmacology and engagement of S1P receptors 1,4,and 5. In addition to UC,it is being investigated for a range of other immuno-inflammatory diseases.
About ELEVATE UC 52 and ELEVATE UC 12
ELEVATE UC 52 and ELEVATE UC 12 are pivotal trials that are part of the ELEVATE UC Phase 3 registrational program.
ELEVATE UC 52 is a randomized,placebo-controlled trial that utilized a treat-through design comprising of a 12-week induction period followed by a 40-week maintenance period. Beginning at week 12,all patients could continue their randomized treatment; patients whose disease had not improved or had worsened compared to baseline could discontinue and,if eligible,enroll in an open-label extension study. The primary objective of this trial was to assess the safety and efficacy of etrasimod 2 mg once daily on clinical remission after both 12 and 52 weeks. The primary endpoint is based on the 3-domain,modified Mayo score (MMS). In ELEVATE UC 52,P≤.001). Statistically significant improvements were attained in all key secondary endpoints,including endoscopic improvement,symptomatic remission,and mucosal healing at weeks 12 and 52,and corticosteroid-free remission and sustained clinical remission at week 52.
ELEVATE UC 12 is a randomized,placebo-controlled trial to assess the efficacy and safety of etrasimod 2 mg once-daily in subjects with moderately-to-severely active UC. The primary objective of this trial was to assess the safety and efficacy of etrasimod on clinical remission at 12 weeks assessed by the FDA-required,3-domain,MMS. In ELEVATE UC 12,P=.0264). All key secondary endpoints were met at week 12,and mucosal healing.
In ELEVATE UC 12,a similar proportion of patients experienced treatment-emergent adverse events (AEs) between etrasimod 2 mg and placebo treatment groups,while in ELEVATE UC 52,it was higher in the etrasimod 2 mg group compared to placebo. The proportion of patients experiencing serious AEs was similar between treatment groups in both trials. The most common treatment-emergent AEs in 3% or more of etrasimod-treated patients and greater than placebo up to week 52 in either trial were headache,worsening of UC,COVID-19 infection,dizziness,pyrexia,arthralgia,abdominal pain and nausea. There were no reports of bradycardia or atrioventricular block as serious AEs. Data support initiation of etrasimod treatment does not require complex up-titration regimen.
Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12,respectively,were naïve to biologic or JAK inhibitor therapy.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality clinical development,regulatory affairs,CMC,business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules,many of which are in late-stage clinical development. The Company's therapeutic areas of interest include cardio-renal diseases,autoimmune disorders,and infectious diseases. For more information,please visit its website at www.everestmedicines.com.
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