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FDA expands golimumab indication


The U.S. FDA has approved to expand the indication for golimumab (SIMPONI ARIA, Janssen Pharmaceutical Companies of Johnson & Johnson) to include it was a treatment for active psoriatic arthritis (PsA) in pediatric patients 2 years and older.

The United States Food and Drug Administration (FDA) has approved to expand the indication of golimumab (SIMPONI ARIA, Janssen Pharmaceutical Companies of Johnson & Johnson) to include treatment for active psoriatic arthritis (PsA) in pediatric patients 2 years and older. The FDA also approved the biologic as a treatment for active polyarticular juvenile idiopathic arthritis (pJIA) for the same age group.

Golimumab, a fully human anti-tumor necrosis factor (TNF)-alpha biologic, is the first and only anti-TNF-α biologic agent administered through intravenous (IV) infusion that is approved by the FDA as a treatment for both pediatric PsA and pJIA, according to a company press release. Golimumab works by targeting soluble and transmembrane bioactive forms of human TNF- α, a protein within the body that can lead to inflammation if overproduced.1

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"This latest FDA approval of SIMPONI ARIA for pediatric use in active pJIA and active PsA not only brings a new option to young patients living with these diseases but also adds to the growing body of evidence for this treatment," says Mathai Mammen, M.D., Ph.D., global head of Janssen Research & Development at Johnson & Johnson. "For more than 20 years, we at Janssen have been committed to researching anti-TNF biologic agents for immune-mediated diseases and are encouraged to expand treatment options for these patients."

The expanded indication approval is supported by positive phase 3 data from Janssen’s GO-VIVA clinical trial, an open-label, single arm, multicenter study investigating the dosing of golimumab in 127 pediatric patients with pJIA with active polyarthritis ages 2 to 17 years with active arthritis in five or more joints despite receiving methotrexate for at least 2 months.1

Results of the study demonstrated similar outcomes to previous studies evaluating golimumab in adult rheumatoid arthritis (RA) patients. Also, the pharmacokinetic (PK) exposure was consistent with results from two other phase 3 trials evaluating the biologic in adult patients with moderate-to-severe active RA and active PsA.1

"Due to the limited availability of pediatric patients for inclusion in clinical trials, it can be challenging to build clinical studies for this young patient population," says Daniel J. Lovell, professor of pediatric rheumatology at Cincinnati Children's Hospital Medical Center. "Given these challenges, I am pleased to see Janssen advance the approval of a new treatment option for pediatric patients with pJIA and PsA – an important milestone in the treatment of these complex, heterogeneous diseases.”

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Golimumab was initially approved by the FDA in 2013 for the treatment of moderate-to-severe active RA, and was later approved in October 2017 for the treatment of adult PsA.2 Currently, it is approved as a combination treatment with methotrexate for adults with moderate-to-severe RA, as well as a monotherapy for active PsA in people 2 years and older, active ankylosing spondylitis (AS) in adults and active pJIA in people 2 years and older.1

"For far too long, children with pJIA or PsA have had limited treatment options," says Seth D. Ginsberg, co-founder and president of the Global Healthy Living Foundation and CreakyJoints. "This approval represents an important step forward for these children and their families."


1. Janssen Pharmaceutical Companies of Johnson & Johnson. (2020, September 30). SIMPONI ARIA® (golimumab) Approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older. Retrieved October 02, 2020, from https://www.prnewswire.com/news-releases/simponi-aria-golimumab-approved-by-the-us-food-and-drug-administration-for-active-polyarticular-juvenile-idiopathic-arthritis-and-extension-of-its-active-psoriatic-arthritis-indication-in-patients-2-years-of-age-and-older-301141976.html?tc=eml_cleartime

2. Johnson & Johnson. (2017, October 20). Retrieved October 02, 2020, from https://www.jnj.com/media-center/press-releases/janssen-receives-two-us-fda-approvals-for-simponi-aria-golimumab-for-the-treatment-of-adults-with-active-psoriatic-arthritis-or-active-ankylosing-spondylitis

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