AbbVie’s Humira Now Indicated to Treat Childhood Arthritis

October 13, 2014

The FDA extended an indication for AbbVie’s Humira to treat childhood arthritis in younger patients, marking another win for the drugmaker seeking to get as much out of the blockbuster biologic before its patents start expiring in two years.

The agency extended Humira’s (adalimumab) indication to treat moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in patients ages two or older. The drug previously could only treat patients age four or older.

JIA is the most common type of childhood arthritis, and polyarticular JIA occurs in about 25 percent of all JIA patients, AbbVie said Monday.

Humira already is approved by the FDA to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis and chronic plaque psoriasis. AbbVie continues to make fervent efforts to expand the indications for the drug, which made up 57 percent of the drugmaker’s 2013 sales. Humira’s patent is set to expire in December 2016 in the U.S. and in April 2018 in Europe.

The FDA recently approved a new indication for Humira to treat children suffering moderate to severe Crohn’s disease.

AbbVie is studying new indications in Phase III trials for Humira to treat the eye inflammation condition uveitis and hidradenitis suppurativa, a skin disease that can lead to lesions and cysts. — 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.