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Apremilast: First Pediatric Approval

Hannah A Blair1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Paediatric Drugs
|November 22, 2024
PubMed

Insights

Apremilast (Otezla®), a PDE-4 inhibitor, is now approved for pediatric plaque psoriasis in the US and EU. This marks a significant milestone for treating moderate to severe cases in children aged six and older.

Area of Science:

  • Dermatology
  • Pharmacology
  • Pediatrics

Background:

  • Apremilast (Otezla®) is a phosphodiesterase-4 (PDE-4) inhibitor.
  • Currently approved for adults with psoriatic arthritis, plaque psoriasis, and Behçet's disease oral ulcers.
  • Pediatric use for plaque psoriasis was previously unaddressed.

Purpose of the Study:

  • To summarize the key milestones in apremilast development.
  • To highlight the regulatory pathway leading to its first pediatric approval for plaque psoriasis.

Main Methods:

  • Review of clinical data for pediatric patients aged 6-17 years.
  • Analysis of regulatory submissions and approvals in the USA and EU.

Main Results:

  • Apremilast received its first pediatric approval in the USA in April 2024 for moderate to severe plaque psoriasis in patients aged ≥6 years.
  • The European Union approved apremilast for the same indication in October 2024 for children and adolescents aged ≥6 years.
  • Both approvals were based on clinical data in pediatric populations meeting specific weight and disease severity criteria.

Conclusions:

  • Apremilast is now an approved treatment option for moderate to severe plaque psoriasis in pediatric patients in both the USA and EU.
  • This expansion of indication addresses a critical unmet need for younger patients requiring systemic therapy or phototherapy.

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