Two new approvals for Janssen’s Simponi Aria

US regulators have expanded the scope of Janssen Biotech’s Simponi Aria to include the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS).

According to the firm, the decision means that the drug - a 30-minute intravenous formulation of golimumab - is now the only fully-human anti-TNF-alpha infused therapy now approved for these conditions and rheumatoid arthritis.

Approval follows clinical trials involving more than 600 patients, in which a higher proportion of patients demonstrated 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) trial, 75 percent of patients receiving the drug, versus 22 percent of patients receiving placebo, achieved at least a 20 percent improvement in the American College of Rheumatology (ACR20) response at week 14, while treatment with Simponi Aria also 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 in the treatment arm compared with 26 percent of patients receiving placebo achieved at least a 20 percent improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) at week 16.

Arthur Kavanaugh, professor of Medicine at the University of California San Diego, and Chair of the GO-VIBRANT steering committee, highlighted the need for new treatment options for patients with PsA, and said the approval of IV golimumab "brings an important new treatment option to patients, especially those who prefer IV administration, and offers one with a 30-minute infusion time".

Atul Deodhar, professor of Medicine at the Oregon Health & Science University in Portland, and Chair of the GO-ALIVE steering committee, also emphasised the limited treatment options for patients with ankylosing spondylitis, and so the approval of Simponi Aria "provides a welcomed new option".