FDA approves intravenous formulation of secukinumab

ByErich Martin

Fact checked byShenaz Bagha

The FDA has approved an intravenous formulation of Cosentyx for use in patients with psoriatic arthritis, ankylosing spondylitis and nonradiographic axial spondyloarthritis, according to a press release from Novartis.

The announcement marks the first time in 6 years that a new intravenous therapy has been approved for PsA, nonradiographic axial SpA and AS, the release said. Additionally, Consentyx (secukinumab, Novartis) is now the sole approved drug in an intravenous formulation specifically targeting interleukin-17A. The drug is also available as a subcutaneous injection.

FDA approval image — “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 eight years of real-world experience," **Christy Siegel,** vice president and head of immunology at Novartis U.S., said in the release.

Philip Mease

“A significant portion of the millions of PsA, AS and nonradiographic axial SpA patients in the United States 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,” 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, said in the release.

“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,” he added.

The intravenous formulation of secukinumab, which will be administered in a monthly 30-minute, weight-based dosing regimen, is expected to be available starting the fourth quarter of 2023.

“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,” Christy Siegel, vice president and head of immunology at Novartis U.S., said in the release.

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FDA approves intravenous formulation of secukinumab

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