STELARA®治疗成人克罗恩病获FDA上市批准

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STELARA® for the treatment of adult Crohn disease was approved by the FDA

2016-09-27 来源：转载自第三方

27 September 2017

On September 26th, Janssen Biotech, Inc. announced that its research and development of STELARA® biotherapy for moderate to severe Crohn's patients has been approved by the FDA. This is the first Crohn's disease therapy to target interleukin-12 and interleukin-23, which plays an important role in inflammation and immunotherapy.

Crohn's disease is a chronic inflammatory bowel disease, can occur in any part of the gastrointestinal tract, the world's incidence is about 5 million. Clinical manifestations are abdominal pain, diarrhea, hematochezia, fatigue, fever. In addition, skin lesions, arthritis, etc. are also common complications. Because of its complex cause, there is no special treatment, the current drug can not completely cure it. The main treatments are drug treatment and surgical treatment, the drug includes salicylic acid (such as sulfasalazine and 5-aminosalicylic acid) and adrenal cortex hormones (hydrocortisone, methylprednisolone or ACTH).

STELARA® is a human monoclonal antibody that targets interleukin-12 and interleukin-23. By targeting these two proteins, new drug developers hope STELARA® can effectively control the inflammatory response. In clinical trials, the dose of STELARA® was based on body weight. After a single STELARA® intravenous injection, the symptoms of 34% (UNITI-1) and 56% (UNITI-2) were relieved within six weeks. In addition, patients conducted every 8 weeks, the vast majority of patients with symptoms of remission can be maintained to 52 weeks. Based on these results, FDA approved STELARA® listed for treatment of adult Crohn's patients. However, STELARA® is a prescription drug and has some side effects on the human body and must be used under the guidance of a professional.

The approval of STELARA® is a major advance in the treatment of Crohn's disease, it provides a different mechanism of action and long-term remission of the disease, which is expected to bring new treatments to these patients.