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This decision by the FDA could offer psoriatic arthritis patients a dosing regimen each month that does not require pre-mediation or regular lab assessments.
Novartis announced that the US Food and Drug Administration (FDA) had given its approval to an intravenous (IV) variant of secukinumab (Cosentyx) as treatment for psoriatic arthritis (PsA), for ankylosing spondylitis (AS), and for non-radiographic axial spondyloarthritis (nr-axSpA) among adult patients.1
The drug is the exclusive IV treatment with the specific purpose of targeting and inhibiting interleukin-17A (IL-17A). It is the only intravenous option for these conditions which does not involve tumor necrosis factor alpha (TNF-α) for its use in each of the conditions.
"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," Philip J. Mease, MD, clinical professor for the University of Washington School of Medicine, said in a statement.
The IV form of secukinumab allows those given the treatment a monthly dosing regimen which is only half an hour and weight-dependent, and the regimen does not require pre-medication or any routine assessments in the lab.
"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,” Mease noted in his statement.
The new IV administration option for patients with the aforementioned forms of arthritis is set to become accessible to them in the fourth quarter of 2023.
Currently, secukinumab is made for those who are 6 and older that have moderate to severe plaque psoriasis which impacts large areas or multiple regions of their body and who may be helped by systemic therapies, injections, or phototherapy.
The treatment is also indicated for those who are 2 and older with active PsA, as well as for adult patients who have active AS, adult patients with active nr-axSpA who show objective signs of inflammation, and those who are aged 4 and up with active enthesitis-related arthritis (ERA).