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Lonapegsomatropin: Pediatric First Approval

Yvette N Lamb1

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

Paediatric Drugs
|October 28, 2021
PubMed

Insights

Lonapegsomatropin, a novel long-acting human growth hormone, is now approved for pediatric growth hormone deficiency. This once-weekly injection offers a convenient alternative to daily treatments.

Area of Science:

  • Endocrinology
  • Pharmacology

Background:

  • Growth hormone deficiency (GHD) affects pediatric patients, necessitating effective treatment.
  • Current treatments for GHD often involve daily injections, posing challenges for adherence.

Purpose of the Study:

  • To summarize the development milestones of lonapegsomatropin.
  • To highlight the first pediatric approval of lonapegsomatropin for GHD.

Main Methods:

  • Review of development history and clinical trial data.
  • Analysis of regulatory submission and approval process.

Main Results:

  • Lonapegsomatropin (lonapegsomatropin-tcgd; SKYTROFA®) is a long-acting prodrug of somatropin.
  • Received US FDA approval in August 2021 for pediatric GHD (age ≥ 1 year, weight ≥ 11.5 kg).

Conclusions:

  • Lonapegsomatropin provides a once-weekly subcutaneous injection for GHD treatment.
  • This long-acting formulation simplifies GHD management, improving patient compliance.

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