HORSHAM, PA, September 30, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Simponi Aria (golimumab) for patients 2 years of age and older for the treatment of active pJIA and has extended the PsA indication for this same patient population.

“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,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, 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.”

About pJIA and PsA

JIA is a group of disorders characterized by arthritis persisting for at least six weeks before the age of 16 years.[i] Approximately 300,000 children suffer from some form of JIA in the United States.[ii] The polyarticular form of JIA is most common and is characterized by inflammation in more than four joints and resembles adult rheumatoid arthritis (RA).[iii] PsA in pediatric patients is one of the rarest subtypes of JIA and is characterized by both joint inflammation and skin lesions associated with psoriasis resembling adult PsA.[iv],[v] Given the heterogeneity of these diseases, additional treatment options are needed for these conditions.

“For far too long, children with pJIA or PsA have had limited treatment options,” said 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.”

Data Supporting Approval

The approval was based on results from the GO-VIVA Phase 3 clinical trial, an open-label study in children with JIA with active polyarthritis ages 2 to 17 years who had active arthritis in five or more joints, despite receiving treatment with methotrexate for at least two months. Trial results demonstrated that pharmacokinetic (PK) exposure of Simponi Aria was consistent with that of two pivotal Phase 3 clinical trials of Simponi Aria in adult patients with moderately to severely active RA and active PsA.

Efficacy was assessed as supportive endpoints through Week 52. The efficacy was generally consistent with responses in adult patients with RA. The adverse reactions observed in GO-VIVA were consistent with the established safety profile of Simponi Aria in adult patients with RA and PsA.

“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,” said Daniel J. Lovell, the Joseph E. Levinson 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.”

Access to Simponi Aria

Janssen strives to work closely with payers, providers and pharmacy benefit managers in an effort to help ensure Simponi Aria is broadly accessible to appropriate patients.

Janssen CarePath offers a comprehensive support program that helps patients get started on Simponi Aria and stay on track. Janssen CarePath provides information on insurance coverage, potential out-of-pocket costs and treatment support, and identifies options that may help make treatment more affordable, including the Janssen CarePath Savings Program for commercially insured patients who are eligible.

About the GO-VIVA Clinical Trial

GO-VIVA is a Phase 3, open-label, single arm, multicenter study conducted across nine countries with treatment received by 127 patients with JIA with active polyarthritis, despite current treatment with methotrexate. GO-VIVA was conducted as a post-marketing requirement under the Pediatric Research Equity Act (PREA) following the initial approval of Simponi Aria for adults with moderately to severely active RA in 2013.

GO-VIVA was designed to evaluate the dosing of Simponi Aria in children that is required to achieve drug levels and exposures that are similar to those that were shown to be safe and effective in adults with moderately to severely active RA, since active pJIA, active PsA in pediatric patients, and adult RA show similarities in disease.

About Simponi Aria (golimumab)

In addition to the treatment of children ages 2 years and older with active pJIA or active PsA, Simponi Aria is approved in the U.S. for the treatment of adults with moderately to severely active RA, active PsA and active ankylosing spondylitis (AS). Simponi Aria is currently approved for one or more of these indications in 24 countries.

Simponi Aria is a fully human anti-TNF-alpha monoclonal antibody that targets both soluble and transmembrane bioactive forms of human TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation.

For adults with RA, PsA, and AS, the Simponi Aria weight-based dosage regimen is 2 mg/kg given as an IV infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter. Simponi Aria is given with methotrexate for the treatment of RA.

For pediatric patients with pJIA and PsA, the Simponi Aria body surface area (BSA)-based dosage regimen is 80 mg/m2 given as an IV infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter.

More information about Simponi Aria is available at www.SimponiARIA.com.

Janssen Biotech, Inc. discovered and developed Simponi Aria.

What is Simponi Aria (golimumab)?

Simponi Aria is a prescription medicine used to treat:

· Moderate to severe rheumatoid arthritis (RA) in adults, used in combination with methotrexate

· Active psoriatic arthritis (PsA) in people 2 years of age and older

· Active ankylosing spondylitis (AS) in adults

· Active polyarticular juvenile idiopathic arthritis (pJIA) in people 2 years of age and older

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal or www.twitter.com/JanssenUS. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding SIMPONI ARIA. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

1. [i] Mayo Clinic. Juvenile idiopathic arthritis. Overview. Accessed September 29, 2020. Available at https://www.mayoclinic.org/diseases-conditions/juvenile-idiopathic-arthritis/symptoms-causes/syc-20374082.
   [ii] National Institutes of Health. U.S. National Library of Medicine. Genetics Home Reference. Juvenile idiopathic arthritis. Frequency. Accessed September 29, 2020. Available at https://ghr.nlm.nih.gov/condition/juvenile-idiopathic-arthritis#.
   [iii] National Institutes of Health. U.S. National Library of Medicine. Genetics Home Reference. Juvenile idiopathic arthritis. Description. Accessed September 29, 2020. Available at https://ghr.nlm.nih.gov/condition/juvenile-idiopathic-arthritis#.
   [iv] Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007;369(9563):767-778.
   [v] Stoll ML, Punaro M. Psoriatic juvenile idiopathic arthritis: a tale of two subgroups. Curr Opin Rheumatol. 2011;23(5):437-443.

Source: Johnson & Johnson
 
 

Posted: September 2020

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