FDA approves Humira for 2-4 year old pediatric polyarticular JIA patients
October 12, 2014 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Humira is one of the world's best-selling drugs, with global sales of $10.6 billion in 2013, ranking first in the 2013 best-selling drug list, and sales in the second quarter of 2014. At $3.29 billion, the drug is AbbVie's flagship product and the world's first approved anti-TNF-α monoclonal antibody with up to eight indications. In late September, the FDA approved the eighth indication of Humira, the pediatric Crohn's disease. Recently, Humira's regulatory aspects have sent good news. The FDA has approved the expansion of Humira pediatric polyarticular juvenile idiopathic arthritis (JIA). Indications for the treatment of 2-4 year old multi-joint JIA pediatric patients. Previously, the FDA has granted Humira the status of orphan drugs for the treatment of 2-4 years old polyarticular JIA.
AbbVie recently announced that the FDA has approved an extension of the age range for indications for Humira pediatric polyarticular juvenile idiopathic arthritis (JIA) for moderate to severe active polyarticular juveniles of 2 years and older Treatment of pediatric patients with arthritis (JIA) to improve symptoms and signs of the patient. Previously, the FDA approved the approval of Humira for the treatment of patients with multi-articular JIA of 4 years and older in 2008. This approval will make Humira an important treatment option for 2-4 year old multi-joint JIA pediatric patients.
Juvenile idiopathic arthritis (JIA) is a persistent or recurrent joint inflammation similar to rheumatoid arthritis, but with an onset time of 16 years or older. The disease is a common connective tissue disease in children under 16 years of age. It is characterized by chronic arthritis. Typical arthritis is characterized by pain, swelling and limited mobility. In addition to joint inflammation and deformity, there are often systemic symptoms and visceral damage such as rash, liver and spleen and lymphadenopathy, pleurisy and pericarditis. Most of the prognosis is good, a small number can cause permanent damage to the joints and chronic iridocyclitis, which is the main cause of disability in children.
Polyarticular JIA accounts for approximately 25% of all JIA cases and is one of seven JIA types involving 5 or more joints. Symptoms include pain, swelling, tender joints, morning stiffness, lameness, and reduced hand and foot activity. Early diagnosis and appropriate treatment are critical in the clinical management of this chronic disease.
In the European Union, Humira was approved in 2008 for the treatment of patients with multi-articular juvenile idiopathic arthritis (JIA) in children and adolescents aged 4-17 years. In 2013, EMA approved the expansion of Humira's age range for polyarticular JIA indications, expanding to the 2-17 year old multi-joint JIA patient population.
In the United States, Humira's eight indications include: moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, moderate to severe Crohn's disease; moderate to severe ulcerative colon Inflammation, ankylosing spondylitis, psoriatic arthritis, moderate to severe polyarticular juvenile idiopathic arthritis, pediatric Crohn's disease.
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