FDA approves once-weekly human growth hormone for children with GH deficiency
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Key takeaways:
- The FDA approved long-acting once-weekly somatrogon for children with growth hormone deficiency.
- Somatrogon was noninferior compared with somatropin in a phase 3 trial.
The FDA in June approved a once-weekly human growth hormone analog for children aged 3 years and older with growth hormone deficiency, according to a company press release.
Somatrogon-ghla (Ngenla, Opko Health and Pfizer) is a long-acting once-weekly injectable human growth hormone approved for children with growth failure due to inadequate secretion of endogenous GH. The FDA’s approval is supported by data from a randomized, open-label, active-controlled phase 3 trial. In the study, somatrogon was noninferior compared with somatropin (Genotropin, Pfizer) for improvements in annual height velocity at 12 months. As Healio previously reported, the findings were similar in a phase 2 trial, where children receiving somatrogon had a 0.33 cm greater mean height velocity at 12 months compared with those receiving somatropin. Somatrogon had a similar safety profile compared with somatropin in phase 2 and phase 3 trials.
“The approval of Ngenla will be significant for children with GH deficiency in the U.S.,” Joel Steelman, MD, a pediatric endocrinologist in the Cook Children’s Health Care System in Fort Worth, Texas, said in the release. “It holds potential to reduce the treatment burden that can come with daily GH injections. As a new, longer-acting option that has the ability to reduce treatment frequency from daily to weekly, Ngenla could become an important treatment option that can improve adherence for children being treated for GH deficiency.”
As Healio previously reported, Pfizer and Opko Health entered into a worldwide agreement in 2014 to develop and commercialize somatrogon. Under the agreement, Opko Health is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product. According to the press release, somatrogon will be available for prescribing in the U.S. in August.
Editors Note: This article was updated on Aug. 31, 2023, to include the brand name for somatropin.
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