Janssen announced it has received FDA approvals for Simponi Aria for the treatment of adults with psoriatic arthritis or active ankylosing spondylitis, according to a company press release.
Simponi Aria (golimumab, Janssen Biotech) is reportedly the only fully-human anti-tumor necrosis factor alpha therapy administered through a 30-minute infusion, for the treatment of PsA and AS. The FDA approvals were based on results from two large-scale, pivotal phase 3 studies that included 600 patients. Patients who received Simponi Aria in both studies demonstrated significant improvements in signs and symptoms of PsA and AS when compared with patients who received placebo.
In the study of the infusion drug for the treatment of active PsA, patients experienced improvement in joint symptoms and inhibition of structural damage. In the study for the treatment of active AS, results showed improvement in measures of disease activity, according to the release.
“Over the past 20+ years, Janssen has been pioneers in addressing the unmet needs of patients living with rheumatologic diseases like PsA and AS,” Andrew Greenspan, MD, vice president of medical affairs at Janssen Scientific Affairs LLC, said in the release. “Simponi Aria has been helping patients with rheumatoid arthritis since its approval in 2013. With today’s FDA approvals, we are pleased to extend the benefits of Simponi Aria to adult patients living with active psoriatic arthritis or active ankylosing spondylitis. We know having all three indications is valuable to rheumatologists and for patients who prefer to have their treatment administered by their health care provider.”
Janssen Biotech plans to work with payers, providers and pharmacy benefit managers to make Simponi Aria accessible for patients and ensure the cost is competitive with other biologic therapies for PsA and AS.