FDA Approves Golimumab for 2 New Indications

The US Food and Drug Administration (FDA) has announced the approval of two Supplemental Biologics License Applications (sBLAs) for golimumab (Simponi Aria, Janssen) for 2 new indications: the treatment of adults with psoriatic arthritis (PsA) and adults with active ankylosing spondylitis (AS).

It is the only fully-human anti-tumor necrosis factor (TNF) alpha therapy that is administered with a 30-minute infusion. It was previously approved in 2013 for the treatment of moderately to severely active rheumatoid arthritis.

The FDA made its decision based on data from 2 clinical trials examining the efficacy of golimumab compared with placebo - GO-VIBRANT for PsA and GO-ALIVE for AS. Patients with PsA showed improvement in symptoms and inhibition of structural damage to joints, and patients with AS showed improvements in disease activity measurements.

"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," Arthur Kavanaugh, MD, a professor of medicine at the University of California San Diego, and the chair of the GO-VIBRANT steering committee, said in a statement. "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."

In GO-VIBRANT, by week 14, 75.1% of patients in the golimumab arm achieved an improvement of at least 20% in the American College of Rheumatology response, compared to 21.8% in the placebo arm (P < 0.001). In addition, 43.6% of patients on the golimumab arm achieved a 50% increase and 24.5% achieved an improvement of 70%.

By week 24, the percentage of patients that had achieved 50% improvement was up to 53.5%, compared to 6.3% in the placebo group.

"At Janssen, our commitment to rheumatology began more than two decades ago with discovery, development and approval of the first anti-TNF-alpha therapy, and since then, we have continued to build upon our portfolio of medicines for patients with immune-mediated diseases," said Newman Yeilding, MD, the head of immunology development, at Janssen Research & Development, said in June when the data was announced. "Data from the GO-VIBRANT study demonstrated how SIMPONI ARIA®, a product already helping people living with moderately to severely active rheumatoid arthritis, may also help those living with psoriatic arthritis, pending its approval in the U.S."

In GO-ALIVE, by week 16, 73% of patients in the golimumab arm achieved a 20% improvement in the Assessment of Spondyloarthritis International Society criteria, compared to 26% in the placebo group. At week 24, patients in the golimumab arm displayed an inhibition of structural joint damage in addition to improved physical function.

"SIMPONI ARIA has been helping patients with rheumatoid arthritis since its approval in 2013,” Andrew Greenspan, MD, the vice president of medical affairs at Janssen Scientific Affairs, said in a statement. “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."