Novartis Bags US FDA Approval For Psoriatic Arthritis Treatment

Novartis announced that the US Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) intravenous (IV) formulation for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA). Cosentyx is the only IV formulation authorised to exclusively target and inhibit interleukin-17A (IL-17A), as well as the only non-tumor necrosis factor alpha (TNF-a) IV option available in all of these indications. Cosentyx's IV formulation provides patients with a monthly 30-minute weight-based dosing alternative that requires no pre-medication or lab monitoring. The new intravenous administration option will be available in Q4 of 2023, as per pharmabiz.

"A significant portion of the millions of PsA, AS and nr-axSpA patients in the US require treatment through IV infusions for a variety of reasons, including not being comfortable with self-injections or simply preferring to have treatments administered in their healthcare provider's office," said Philip J. Mease, M.D., Clinical Professor at the University of Washington School of Medicine and Director of Rheumatology Research at the Swedish Medical Center in Seattle, WA. "The approval of Cosentyx as an IV formulation is an important milestone for patients because it expands the treatment options available to them with a different mechanism of action than existing biologic IV therapies, along with the comfort and familiarity of an established treatment." Cosentyx is a fully human biologic that specifically targets and blocks the cytokine interleukin-17A (IL-17A), which is involved in the inflammation of psoriatic arthritis (PsA), moderate to severe plaque psoriasis, ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA).