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FDA Greenlights Intravenous Formulation Of Secukinumab: A New Era In Treatment

The FDA has approved Novartis’ intravenous (IV) form of Cosentyx (secukinumab) for the treatment of patients with psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA). The new IV administration method will launch in the fourth quarter of 2023.

The 30-minute monthly weight-based dose option is available with Cosentyx’s IV formulation. Interleukin-17A (IL-17A) is the target of the self-injectable medicine Cosentyx, which inhibits it. The injection formulation has a list price of $6,924.26 for a month’s supply.

Intravenous Secukinumab Approved By FDA

Cosentyx is a well-known drug studied therapeutically for more than 14 years. Eight years of adult real-world data and five years of long-term safety and efficacy in adults with moderate to severe plaque psoriasis, PsA, and AS provide the medicine with strong supporting evidence. These results support the use of Cosentyx as a treatment for AS, nr-axSpA, PsA, moderate-to-severe adult and pediatric plaque psoriasis, and two subtypes of juvenile idiopathic arthritis (JIA), enthesitis-related arthritis and juvenile psoriatic arthritis.

Intravenous Secukinumab Approved

Since Cosentyx’s introduction in 2015, more than 1 million patients have received treatment. More than 100 nations have approved Cosentyx, with Europe most recently approving it for JIA and hidradenitis suppurativa.

The immune system, your body’s first line of defense against disease, is stimulated by monoclonal antibodies. Monoclonal antibodies are what Cosentyx is categorized as. Specific proteins produced by your immune system may lead to inflammation. Interleukin 17A (IL-17A) belongs to this class of proteins. It has been linked to both plaque psoriasis and psoriatic arthritis in studies. Psoriasis symptoms may worsen as a result of IL-17A’s actions. Researchers have discovered that people with psoriatic arthritis and plaque psoriasis have greater blood levels of IL-17A than people without these illnesses.

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The organization’s spokesman said the IV formulation’s $2,115 wholesale acquisition cost per vial was competitive with comparable IV biologics. According to the spokesperson, they collaborate closely with payers and healthcare systems to develop medical policies and coverage based on the clinical value and patient benefits Cosentyx provides.

Novartis created the IV formulation of Cosentyx in response to the demand for more options for patients who might not feel comfortable administering themselves beneath the skin, prefer in-office administration by a healthcare professional, or might be interested in an alternative mechanism of action to other biologic IV therapies for these conditions that do not come with a boxed warning or call for pre-medication or lab monitoring.

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According to 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, a sizable portion of the millions of PsA, AS, and nr-axSpA patients in the United States need treatment through IV infusions for a variety of reasons, such as feeling uncomfortable with self-injections or simply preferring to have treatments administered in their healthcare provider’s office.

The model-informed drug development (MIDD) pipeline, a method for accelerating regulatory decision-making, was used by Novartis and the FDA. This process enables the FDA to make choices based on simulations and mathematical models of pharmacokinetics, how the body interacts with the medicine, and pharmacodynamics, or how the drug affects the body.

This method sets the dose at the highest concentration of the 300 mg subcutaneous injection, which was looked at in 11 prior clinical investigations for Cosentyx. According to the Novartis spokeswoman, the blood level of the medicine was found to be between the estimated steady-state concentrations of Cosentyx 150 mg and 300 mg when delivered subcutaneously at the recommended dose of 1.75 mg/kg every four weeks, with or without a loading dose.

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