AbbVie’s Humira Gets Indication to Treat Pediatric Crohn’s Disease Patients

With patent expirations looming, AbbVie secured a new indication for its blockbuster biologic Humira to treat children suffering from moderate to severe Crohn’s disease.

The agency approved Humira (adalimumab) to reduce signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn’s disease patients six years or older when certain treatments for the inflammatory bowel disease (IBD) didn’t work, AbbVie said last week. In 2012 the European Commission approved the same indication for Humira, the company added.

The FDA approved the indication based on results from a Phase III trial that evaluated multiple dosing strategies of Humira to treat Crohn’s in pediatric patients. The new indication was fast tracked per the agency’s Orphan Drug program.

The drug already is approved in the U.S. and Europe to treat Crohn’s disease in adults, the IBD condition ulcerative colitis and multiple types of arthritis and psoriasis.

Humira has been massively successful for AbbVie, generating $5.9 billion in sales in the second quarter of this year, according to the company’s latest financials. The drug also accounted for 57 percent of AbbVie’s total sales in 2013.

However, the drug’s patent is expected to expire in December 2016 in the U.S. and in April 2018 in Europe.

AbbVie is studying other new indications for Humira. For example, the drugmaker is currently conducting Phase III trials to support U.S. and European regulatory applications for Humira to treat the eye inflammation condition uveitis and hidradenitis suppurativa, a disease that creates lesions and cysts on the skin.

AbbVie did not return a request for comment as of press time. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.