FDA Approves Janssen’s Golimumab for PsA, AS

Monday, October 23, 2017 | FDA Approval/Clearance , Psoriasis , Product Launches and Updates


 

The FDA approved Janssen’s SIMPONI ARIA (golimumab) for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS).

Simponi is the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion.The new approvals follow the first FDA approval of SIMPONI ARIA® in 2013 for the treatment of moderately to severely active rheumatoid arthritis (RA).

The PsA and AS approvals are supported by comprehensive clinical development programs that demonstrated the significant efficacy of SIMPONI ARIA® over placebo, while offering a consistent safety profile across all indications. In the study for the treatment of active PsA, patients experienced improvement in joint symptoms and inhibition of structural damage. In the study for treatment of active AS, results showed improvement in measures of disease activity.

"There is a need for new treatment options for patients with psoriatic arthritis. The results of the Phase 3 study of intravenous (IV) golimumab in patients with psoriatic arthritis demonstrated significant and clinically important efficacy across various domains including the inhibition of structural damage," says Arthur Kavanaugh, MD, Professor of Medicine, University of California San Diego, and Chair of the GO-VIBRANT steering committee, in a news release. "The approval of IV golimumab for the treatment of active psoriatic arthritis brings an important new treatment option to patients, especially those who prefer IV administration, and offers one with a 30-minute infusion time."

The approvals of SIMPONI ARIA® for PsA and AS are based on two large-scale, pivotal Phase 3 studies involving more than 600 patients. In both studies, the primary endpoints were met, with a higher proportion of patients demonstrating significant improvement in the signs and symptoms of PsA and AS in the groups receiving treatment with SIMPONI ARIA® compared with those receiving placebo. In the GO-VIBRANT (PsA) study, 75 percent of patients receiving SIMPONI ARIA®, compared with 22 percent of patients receiving placebo (P < 0.001), achieved at least a 20 percent improvement in the American College of Rheumatology (ACR20) response at week 14. Treatment with SIMPONI ARIA®resulted in the inhibition of the progression of structural joint damage and improvement in physical function associated with PsA at week 24. In the GO-ALIVE (AS) study, 73 percent of patients receiving SIMPONI ARIA®, compared with 26 percent of patients receiving placebo (< 0.001), achieved at least a 20 percent improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) at week 16. ACR20 and ASAS20 are standard measures used to assess clinical improvement in PsA and AS, respectively.

Janssen will work with payers, providers and pharmacy benefit managers to ensure SIMPONI ARIA® is broadly accessible for patients and that the cost for payers is competitive with currently available biologic therapies for PsA and AS. The Janssen CarePath Savings Program offers an affordability option for SIMPONI ARIA®, where eligible commercial patients pay just $5 for each infusion for SIMPONI ARIA® medication costs. See full details and eligibility requirements here.

 

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