FDA Approves Rx to Treat Crohn's Disease in Kids

Humira approved to treat moderate to severe pediatric Crohns disease

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new treatment for Crohn's disease in children. It is the first treatment for pediatric Crohn's approved to be administered at home.

The FDA approved Humira (adalimumab) Thursday to treat kids between 6 and 17 years old who have moderate to severe Crohn's disease.

The approval came after successful testing of the treatment.

"Moderate to severe Crohn's disease is a serious chronic disorder that can impact children and adolescents in significant ways during this important stage of their lives," said Jeffrey S. Hyams, MD, head of the Division of Digestive Diseases, Hepatology and Nutrition at the Connecticut Children's Medical Center, in a press release. "The approval of Humira for this patient population offers a new important treatment option for physicians and their patients that can help address this sometimes debilitating disease."

Crohn's is a chronic disease that inflames the intestines. Symptoms include stomach pain, weight loss and diarrhea.

Around 38,000 US kids and teens have the disease, according to a press release from AbbVie, which markets Humira. Crohn's is often more severe when it appears in childhood.

Humira, an injectable treatment, is the first treatment approved for home use for kids with Crohn's disease. It will likely require training on safe needle practices before home use. The treatment has been approved in Europe since 2012.

Humira is approved to treat kids with severe Crohn's disease who have not responded to conventional treatments. It has previously been approved to treat other diseases, including psoriasis, arthritis and Crohn's disease in adults.

Humira can weaken the immune system, making the body unable to fight off infections. AbbVie also notes that patients using Humira should not receive live vaccines.

The risk for certain cancers may increase with Humira use, AbbVie notes.

Other side effects include redness or swelling near the injection site, headaches and nausea.

Review Date: 
September 25, 2014
Last Updated:
October 8, 2014