AbbVie's HUMIRA® (Adalimumab Injection) Approved in China for Treatment of Moderately to Severely Active Pediatric Crohn's Disease in Patients Aged 6 and Older

AbbVie's Product Humira®(Adalimumab Injection) Approved in China for the Treatment of6Moderate to Severe Active Pediatric Crohn's Disease in Patients Aged ≥X Years

− Humira®(Adalimumab Injection) has been approved by the National Medical Products Administration of China(NMPA)Approved for the treatment of6Moderate to Severe Active Pediatric Crohn's Disease in Patients Aged ≥6 Years(ped CD), becoming the only biologic agent currently approved in mainland China for the subcutaneous treatment of this disease via a prefilled injection device throughout the entire course of therapy, thereby providing patients with a flexible and convenient treatment option.

− Crohn’s disease is a chronic, relapsing inflammatory condition that involves the full thickness of the intestinal wall. In pediatric patients, nutritional impairment resulting from chronic diarrhea, anorexia, and chronic wasting can severely affect normal growth and pubertal development, manifesting as significant growth retardation and imposing substantial therapeutic, economic, and psychological burdens on affected children and their families.

− Pediatric Crohn's Disease(ped CD)The indication is Humira.®(Adalimumab Injection) The eighth indication approved in China, following rheumatoid arthritis, ankylosing spondylitis, psoriasis, adult Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, and pediatric plaque psoriasis, and also the third pediatric indication.

AbbVie, a global biopharmaceutical company(AbbVie)Announced, the National Medical Products Administration of China(NMPA)Already on2021Year4Month20Approved Humira on [Date]®(Adalimumab Injection) is indicated for the treatment of patients who have an inadequate response to corticosteroids or immunomodulators (e.g., azathioprine,6-Mercaptopurine, Methotrexate) inadequate response6HUMIRA® reduces signs and symptoms, induces and maintains clinical remission in pediatric patients aged 6 years and older with moderately to severely active Crohn’s disease.®(Adalimumab Injection) is currently the only fully human monoclonal antibody approved in mainland China for the subcutaneous treatment of this disease via a pre-filled syringe throughout the entire course of therapy.TNFα monoclonal antibody provides patients with a new treatment option. This is Humira®(Adalimumab Injection) The eighth indication approved in China, also for Humira®The third pediatric indication approved for (Adalimumab Injection).

Crohn’s disease is a chronic inflammatory condition that involves the full thickness of the intestinal wall. Its chronic course, persistent nature, and propensity for relapse, along with potential extra-intestinal manifestations and complications (such as strictures, fistulas, or abscesses) that may necessitate surgical intervention, significantly impair patients’ quality of life. In pediatric patients, nutritional impairment resulting from chronic diarrhea, decreased appetite, and chronic wasting severely affects normal growth and pubertal development, manifesting as significant growth retardation and imposing substantial therapeutic, economic, and psychological burdens on affected children and their families. Conventional treatment for pediatric Crohn’s disease includes induction of remission with exclusive enteral nutrition and corticosteroids, followed by maintenance therapy with immunomodulators.[ Sauer CG, Kugathasan S. Pediatric inflammatory bowel disease: highlighting pediatric differences in IBD. Med Clin North Am. 2010;94:35–52.], but some pediatric patients remain unresponsive to conventional therapy and may even experience exacerbated growth impairment due to treatment.[ Markowitz J, Grancher K, Rosa J, et al. Growth failure in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 1993;16:373–380.]、[ Issenman RM. Bone mineral metabolism in pediatric inflammatory bowel disease. Inflamm Bowel Dis. 1999;5:192–199.], there is an urgent clinical need for more effective therapies and medications to induce and maintain remission.

As a pediatric medication with significant clinical advantages, this time Humira®(Adalimumab Injection) The application for the pediatric Crohn's disease indication was approved by the Center for Drug Evaluation of the National Medical Products Administration(CDE)Waiver of eligibility for clinical trials registered in China. Its approval was based on two studies evaluating Humira®(Adalimumab Injection) Treatmentped CDPivotal Global Randomized, Double-Blind Study on Efficacy and Safety3Phase I Clinical StudyIMAgINE 1and Its Open-Label Extension StudyIMAgINE 2。IMAgINE 1Studies have shown that after open-label induction therapy with adalimumab (dose: ≥40 kgThe subjects were160/80 mg，<40 kgof the subjects were80/40 mg), double-blind maintenance dose regimen (low dose10 mg，BW<40 kg, or20 mg，BW≥40 kg; Standard dose20 mg，BW<40 kg, or40 mg，BW≥40 kg) can effectively induce and maintain moderate to severeCDof6To17clinical remission in pediatric subjects aged years through week52Zhou.IMAgINE 2The study included participants who successfully completed the52Zhou'sIMAgINE 1Study subjects (including some patients with prior infliximab exposure), up to240Weekly adalimumab therapy maintains stable clinical remission and response rates[ Heuschkel R, Salvestrini C, Beattie RM, et al. Guidelines for the management of growth failure in childhood inflammatory bowel disease. Inflamm Bowel Dis. 2008;14:839–849.]。IMAgINE 2 In the study, previousIFX Exposure did not affect the clinical remission and response rates in subjects. No new safety signals were observed during the two studies.[ JEFFREY S. HYAMS et al. GASTROENTEROLOGY 2012;143:365–374]、[ William A. Faubion et al. Inflamm Bowel Dis Volume 23, Number 3, March 2017]。

Ossian Ou, Global Vice President and General Manager of AbbVie China, stated:“Thanks to the effective implementation of supportive policies in China that accelerate the review and approval of innovative pediatric drugs, Humira®The third pediatric indication—pediatric Crohn’s disease—received rapid approval, promising a higher-quality and more convenient treatment experience for Chinese pediatric patients and their families. As a leader in the field of immunology, AbbVie continues to strive to fulfill its commitment to “introducing more Humira to China.”®“commitment to improving the patient experience, particularly for pediatric patients; meanwhile, we are actively advancing the launch of more innovative therapies in this field in China, with the expectation of meeting the treatment needs of diverse patient populations.”

2006Year, Humira®(Adalimumab Injection) Pediatric Crohn’s Disease Indication Approved by the U.S. Food and Drug Administration (FDA) “Orphan Drug” Designation[ FDA Search Orphan Drug Designations and Approvals]. Currently, internationally, including the United States and the European Union,86countries and regions have approved Humira®(Adalimumab Injection) for pediatric patients with Crohn's disease.

 1 Sauer CG, Kugathasan S. Pediatric inflammatory bowel disease: highlighting pediatric differences in IBD. Med Clin North Am. 2010;94:35–52.

 2 Markowitz J, Grancher K, Rosa J, et al. Growth failure in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 1993;16:373–380.

 3 Issenman RM. Bone mineral metabolism in pediatric inflammatory bowel disease. Inflamm Bowel Dis. 1999;5:192–199.

 4 Heuschkel R, Salvestrini C, Beattie RM, et al. Guidelines for the management of growth failure in childhood inflammatory bowel disease. Inflamm Bowel Dis. 2008;14:839–849.

 5 JEFFREY S. HYAMS et al. GASTROENTEROLOGY 2012;143:365–374

 6 William A. Faubion et al. Inflamm Bowel Dis Volume 23, Number 3, March 2017

 7FDA Search Orphan Drug Designations and Approvals