FDA Extends RA Drug Approval for PsA, AS

10/23/2017

The US Food and Drug Administration recently approved Simponi Aria (golimumab) for the treatment of adult patients with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS), which is administered as a 30-minute infusion.
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Simponi Aria was originally approved in 2013 for the treatment of moderate-to-severe active rheumatoid arthritis. This new approval was based on data from 2 large-scale pivotal phase 3 trials that demonstrated significant improvements in signs and symptoms of PsA and AS in adult patients compared with placebo.

Common adverse effects included upper respiratory infections, abnormal liver tests, decreased blood cells that fight infections, viral infections, bronchitis, high blood pressure, and rash.

—Melissa Weiss

Reference:

Janssen receives two U.S. FDA approvals for Simponi Aria (golimumab) for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis [press release]. Hoshram, PA: Janssen, October 20, 2017]. http://www.janssen.com/us/sites/www_janssen_com_usa/files/janssen_receives_two_us_fda_approvals_for_simponi_aria_golimumab_for_the_treatment_of_adults_with_active_psoriatic_arthritis_or_active_ankylosing_spondylitis.pdf.