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FDA OKs new indications for Janssen’s Simponi Aria

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HORSHAM, Pa. — Janssen Biotech Inc. has gained Food and Drug Administration approval for Simponi Aria (golimumab) to treat adults with active psoriatic arthritis or active ankylosing spondylitis.

Janssen said Simponi Aria is the only fully-human anti-tumor necrosis factor-alpha therapy administered via a 30-minute infusion. The latest indication follows Simponi Aria’s first FDA approval in 2013 for the treatment of moderately to severely active rheumatoid arthritis.

An estimated more than 1 million Americans are living with psoriatic arthritis, and up to 30% of patients with psoriasis can develop the condition, which causes pain, stiffness and swelling in and around the joints.

Ankylosing spondylitis, a chronic, immune-mediated disease of the axial skeleton, affects the sacroiliac joints and the spine. The disease frequently also causes enthesitis, which is inflammation where ligaments and muscles attach to bones, most commonly those within the spine. It’s estimated that 700,000 people in the United States have ankylosing spondylitis.

“Over the past 20-plus years, Janssen has been pioneers in addressing the unmet needs of patients living with rheumatologic diseases like psoriatic arthritis and ankylosing spondylitis,” stated Andrew Greenspan, vice president of medical affairs at Janssen Scientific Affairs. “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 healthcare provider.”

Janssen said it 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 psoriatic arthritis and ankylosing spondylitis. The company added that the Janssen CarePath Savings Program offers an affordability option for Simponi Aria, in which eligible commercial patients pay $5 for each infusion.


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