FDA Approves Secukinumab Label Update for Psoriatic Arthritis
JUNE 19, 2018
Cecilia Pessoa Gingerich
Marcia Kayath, MDThe US Food and Drug Administration (FDA) has approved a label update for secukinumab (Cosentyx, Novartis) that includes new evidence that the treatment significantly impedes the progression of joint structural damage at 24 weeks compared to placebo for patients with active psoriatic arthritis.
"While daily psoriatic arthritis symptoms can seriously affect a patient, the progressive nature of this disease should not be ignored. The joint damage that often results from having the disease over time can potentially be permanent," said Marcia Kayath, MD, PhD, MBA, Head US Clinical Development and Medical Affairs, Novartis.
Secukinumab is a human monoclonal antibody that selectively binds to the interleukin-17A cytokine, impeding its interaction with the IL-17 receptor. The drug is now the only interleukin-17A antagonist approved to treat active psoriatic arthritis, active ankylosing spondylitis, and moderate to severe plaque psoriasis in adults.
The update to the secukinumab prescribing information is supported by results from the FUTURE 5 study of patients (n=996) with active psoriatic arthritis. Participants were randomized to 4 groups: secukinumab 300 mg with loading dose (LD), 150 mg with LD, 150 mg without LD, or placebo. All groups received treatment or placebo at baseline, at weeks 1, 2, 3, and 4, and then every 4 weeks.
"Now physicians and their patients with psoriatic arthritis can be confident that Cosentyx not only offers significant symptom relief, but also helps slow the progression of the disease," said Kayath.
Earlier this year, the label for secukinumab was updated to include treatment for moderate-to-severe scalp psoriasis. The drug was first approved by the FDA for plaque psoriasis in January 2015.
Secukinumab is currently approved for use in over 75 countries, including the US and European Union countries, for all indications. The indications include the treatment of psoriatic arthritis, psoriasis, and ankylosing spondylitis.
The new data for secukinumab will be added to the prescribing information and the change is effective in the US immediately.