Novartis Cosentyx IV formulation for rheumatic diseases bags USFDA okay
The IV formulation of Cosentyx offers patients a monthly 30-minute, weight-based dosing option, requiring no pre-medication and no lab monitoring.;
East Honover: Novartis has announced that the US Food and Drug Administration (FDA) has approved an intravenous (IV) formulation of Cosentyx (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).
"Cosentyx is the only treatment approved in an IV formulation that specifically targets and blocks interleukin-17A (IL-17A), and the only non-tumor necrosis factor alpha (TNF-α) IV option available in all these indications," the Company claimed.
The IV formulation of Cosentyx offers patients a monthly 30-minute, weight-based dosing option, requiring no pre-medication and no lab monitoring. The new IV administration option will be available in Q4 of 2023.
"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."
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