Dabital, an innovative first-line treatment for atopic dermatitis, has been approved for pediatric indications

2022-05-11 0 By

Abstract: As the first targeted biologic agent for the treatment of moderate to severe atopic dermatitis, more than 350,000 patients worldwide have received effective treatment.On February 24, Darbitol, a first-line innovative treatment for atopic dermatitis, was approved by the National Medical Products Administration (NDA) to expand its use to treat moderate and severe atopic dermatitis in children and adults aged 6 years and older who are poorly controlled or not recommended for the use of exogenous drugs.The approval of this pediatric indication means that it is the only targeted biologic approved for the treatment of moderate to severe atopic dermatitis in children, adolescents and adults in China, and will bring a new safe and effective treatment option to a wider patient population.The approval of the new indication for children is based on a key global phase iii clinical trial in children and extrapolation of data on indications for moderate to severe atopic dermatitis in adults and adolescents in China.This is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of dabital in combination with topical corticosteroids in the treatment of severe atopic dermatitis in children.More than twice as many patients in the dabital and topical corticosteroid group had skin lesions cleared or nearly cleared, and more than four times as many had significant itching relief, with an average improvement of about 80 percent, according to the trial.Atopic dermatitis is a systemic immune disease caused by a type 2 inflammatory response that used to be described simply as “eczema”.This is a systemic disease in the form of skin disease, often accompanied by allergic rhinitis, asthma and other type 2 inflammatory diseases.Eighty-five to 90% of patients with atopic dermatitis are younger than five years of age at the time of symptom onset or onset and have not received effective treatment for many years by childhood.Episodes in children with atopic dermatitis, skin often appear the symptom of severe itching and skin lesions, cause skin cracking, erythema, papules, seepage, the serious influence children’s study life, mind and body development and healthy growth, including psychological mood, sleep, concentration and quality of life, and anxiety, depression and other psychological problems may come up.According to Professor Yao Zhirong, director of dermatology department of Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine, atopic dermatitis is a common childhood disease with high incidence, and most of them are mild atopic dermatitis, which can be well controlled after routine treatment, but there are still some cases of resistance to existing treatment and poor symptom control.A number of clinical and real-world studies have confirmed that dabidine can be effective and safe, without inhibiting growth and development, which is of great significance for long-term disease control and improvement of life quality in children with atopic dermatitis.Dabital has been approved in more than 60 countries and regions around the world. In May 2019, dabital was included in the list of the second batch of clinically urgent overseas New Drugs of the Drug Evaluation Center of the State Food and Drug Administration, speeding up the approval process.It was approved in June 2020 and has now been included in the national medical insurance directory.Declaration: The copyright of this article belongs to the original author, if there is a source error or infringement of your legitimate rights and interests, you can contact us through the mailbox, we will promptly deal with.Email address: jpbl@jp.jiupainews.com