FDA approves Zoryve for pediatric psoriasis
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Key takeaways:
- Zoryve is a nonsteroidal topical treatment previously indicated for patients aged 12 years and older.
- This approval expands the indication to include children aged 6 to 11 years.
The FDA has approved a supplemental new drug application for Zoryve expanding its indication to include treatment of psoriasis in pediatric patients, Arcutis Biotherapeutics announced in a press release.
A topical phosphodiesterase (PDE4) inhibitor, Zoryve (roflumilast cream 0.3%) is a nonsteroidal option for psoriasis treatment, including in intertriginous areas, that was previously approved in patients aged 12 years and older.
This approval expands that indication to include children aged 6 to 11 years.
“Young children with plaque psoriasis lack treatment options, which is why today’s decision by the FDA represents a meaningful advancement for this pediatric population, their parents and caregivers,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, said in the release. “Zoryve has been shown to be safe, well tolerated, and effective — all critical factors for treating children with plaque psoriasis. We are excited to now be able to expand the availability of Zoryve to children as young as 6 years old, offering them and their families an important new steroid-free treatment option to consider along with their health care providers.”
Perspective
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Roflumilast, a phosphodiesterase inhibitor (of PDE4) is currently used systemically for the treatment of advanced COPD. The medication has been formulated into a 0.3% cream for cutaneous use, as inflammatory skin disease involves upregulation of phosphodiesterase. Topical phosphodiesterase inhibitors have been effective in the treatment of atopic dermatitis, and expanding the scope of use of this drug class is an opportunity to alleviate disease burden for more patients. Roflumilast is FDA approved as an alternative therapy to topical steroids for plaque psoriasis in patients older than 12.
Recent trials on children aged 6 to 11 years show the medication to be safe and effective for children as well, with minimal side effects. As such, roflumilast is now FDA approved for use in children aged 6 to 11 years, including use in intertriginous areas.
This is a great advance in medical treatment for a common pediatric skin disease, as one-third of psoriasis cases begin in childhood; it is the second most common inflammatory skin disease in children after atopic dermatitis and greatly impacts patient quality of life. Trials to assess safety and efficacy in children aged 2 years and older are currently underway. It is important to have alternative treatment options for patients who are unable to tolerate traditional first-line therapies or have disease that is refractory to those medications. Similarly, it is of utmost importance research on skin disease in children continues so that as advanced medical therapies become available to patients, children are given expanded therapeutic options that are safe and effective. This is a positive expansion of the armamentarium available to address pediatric psoriasis.
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