Humira receives FDA approval for treating pediatric patients with Crohn’s disease

FDA has approved adalimubab (Humira, AbbVie) to treat pediatric patients with moderate to severe Crohn’s disease.

FDA approves treatment for ulcerative colitis and Crohn’s 

Crohn’s disease is an inflammatory bowel disease (IBD) that commonly involves the end of the small intestine and the large intestine. It is most often diagnosed in adolescents or young adults, but can present at any age.

The approval is to treat pediatric Crohn’s patients aged 6 years and older who have not had success with other treatments options. An estimated 38,000 children and teens in the United States have Crohn’s disease. There is no known cure for Crohn’s disease, and one of the treatment goals is to induce and maintain remission.

“Humira's approval for use in pediatric Crohn's patients strengthens AbbVie's franchise drug and allows the company to continue to penetrate a market with room to grow,” said John Santilli of Access Market Intelligence, which provides market intelligence to the pharmaceutical and healthcare industries.

“With this approval, Humira can be administered at home for this patient population which gives the AbbVie a competitive advantage as it gets closer to patient expiration. Doctors familiarity with Humira, its side effects and clinical studies will be reassuring for formulary managers," he added.

Humira inhibits tumor necrosis factor-alpha (TNF-α). It can be self-administered after proper training with physician oversight.

The European Commission in 2012 approved Humira as a treatment for pediatric Crohn’s disease for patients aged 6 to 17 years who had not tolerated or responded to conventional treatments. 

FDA approval was supported by the phase 3 IMAgINE-1 trial, the largest multi-center, randomized, double-blind anti-TNF trial in patients age 6 to 17 years with moderately to severely active Crohn’s disease.

Humira received prior approval as a treatment for adult rheumatoid arthritis, adult Crohn’s disease, juvenile idiopathic arthritis, ulcerative colitis, and soriatic arthritis, Ankylosing spondylitis, and plaque psoriasis in adults.

Related

AbbVie acquires Shire amid looming Humira biosimilar competition