FDA Approves Secukinumab as First Intravenous Interleukin-17A Antagonist for Rheumatic Diseases

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The intravenous formulation of secukinumab is administered in monthly 30-minute, weight-based dosing and requires no pre-medication or lab monitoring.

The FDA has approved an intravenous (IV) formulation of secukinumab (Cosentyx; Novartis) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondylarthritis (nr-axSpA), making it the first IV formulation that specifically targets and blocks interleukin-17A (IL-17A) and the only non-tumor necrosis factor alpha (TNF-a) IV option available in these indications.1

According to the company, the IV formulation is administered in monthly 30-minute, weight-based dosing and requires no pre-medication or lab monitoring. It will be available in the fourth quarter of 2023, according to Novartis.1

“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 health care provider’s office,” said Philip J. Mease, MD, clinical professor at the University of Washington School of Medicine and Director of Rheumatology Research at the Swedish Medical Center in Seattle, Washington, in a press release.1

Secukinumab is a fully human biologic that targets and blocks IL-17A, an important cytokine involved in the inflammation of PsA, moderate to severe plaque psoriasis, AS, and nr-axSpA. Data supporting secukinumab’s use include 8 years of real-world data in adults and 5 years of long-term safety and efficacy data in adults with moderate to severe plaque psoriasis, PsA, and AS.1

“With this approval of Cosentyx as an IV formulation, along with the subcutaneous formulation, we can broaden the use of Cosentyx to help more patients manage their condition with a medicine backed by more than a decade of clinical research and 8 years of real-world experience,” said Christy Siegel, vice president and head of Immunology at Novartis US, in the press release.1

The IV formulation offers a new dosing option, in addition to research that has shown gradually increasing the dosing interval of secukinumab produced outcomes consistent with the recommended dosing schedule for patients receiving the subcutaneous formulation. In a study of 83 adults with moderate to severe plaque psoriasis, the cohort of patients whose injection intervals were guided by baseline Psoriasis Area and Severity Index (PASI) scores showed improvements in skin lesions throughout the study.2

The average PASI score was 21.53 at baseline, decreased to 3.71 at week 4, hit a low of 0.59 at week 12, and increased to 1.047 at week 24. The average score was 1.38, demonstrating near absence of disease at week 36.2

Increasing the number of dosing options for patients offers new opportunities to meet patient needs, according to Novartis.

“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 or an established treatment,” Mease said in the press release.1

References

  1. FDA approves Novartis Cosentyx as first intravenous (IV) formulation interleukin-17A antagonist for rheumatic diseases. News release. PR Newswire. October 6, 2023. Accessed October 9, 2023. https://www.prnewswire.com/news-releases/fda-approves-novartis-cosentyx-as-first-intravenous-iv-formulation-interleukin-17a-antagonist-for-rheumatic-diseases-301949928.html?tc=eml_cleartime
  2. McNulty R. Secukinumab Dosing Intervals Based on Treatment Response Show Safety, Efficacy in Patients with Psoriasis. Pharmacy Times. December 8, 2022. Accessed October 9, 2023. https://www.pharmacytimes.com/view/secukinumab-dosing-intervals-based-on-treatment-response-show-safety-efficacy-in-patients-with-psoriasis
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