The Food and Drug Administration (FDA) has approved Johnson & Johnson's (NYSE: JNJ ) psoriatic arthritis treatment Stelara for patients 18 years or older, the company announced Monday. The approved treatment consists of 45 mg injections of Stelara at 0 and 4 weeks, then once every 12 weeks.
Additionally, Stelara has been approved by the European Commission, following a positive recommendation of the treatment's use from the Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency. According to JNJ, 4.2 million people in Europe are currently afflicted with the disease, as well as more than 2 million in the U.S.
Psoriatic arthritis is a form of arthritis that causes joint pain, stiffness, and swelling in patients with psoriasis. The Food and Drug Administration approved Stelara in 2009 as a treatment for psoriasis. Revenue from the drug rose 50% to $371 million in the second quarter. The latest FDA and EC approvals could increase sales of Stelara.
According to JNJ, both the FDA and the EC made their decisions based on the results of the PSUMMIT I study, which "demonstrated the efficacy and safety of STELARA in one of the largest clinical development programs ever conducted for the treatment of active psoriatic arthritis," according to Jerome Bascia, vice president of Janssen Research and Development, a pharmaceutical company branch of Johnson & Johnson.
Cindy Guzzo, Janssen Biotech's Vice President of Medical Affairs, was quoted as saying the company was "proud to expand our portfolio of biologic treatment options for patients living with psoriatic arthritis to include an anti-IL-12/23 therapy such as Stelara ... a meaningful new option for patients battling this chronic condition."
European regulators also cleared Johnson & Johnson's drug Simponi as a treatment for ulcerative colitis, an inflammatory bowel disease. Worldwide sales of Simponi, which also treats rheumatoid arthritis, rose 40% to $175 million during the second quarter.
-- Material from The Associated Press was used in this report.