If you’ve been waiting anxiously (must ask why?) for yet another human growth hormone to be approved..... then wait no longer.
The FDA recently approved a new therapy, Ngenla (somatrogon-ghla) from Pfizer, a once-weekly, human growth hormone (hGH) analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
Human growth hormone works by replacing insufficient growth hormone in the body. Ngenla is administered subcutaneously and must be dosed based on patient weight. Ngenla is available in two single-patient-use, disposable, prefilled pens: a 24 mg/1.2 mL (20 mg/mL) with 0.2 mg increments and also a 60 mg/1.2 mL (50 mg/mL) pen with 0.5 mg increments.
Various clinical sources cite prevalence levels of ~1/ 4000-10000 children aged 3+-18 years old with inadequate secretion of endogenous growth hormone. There are an estimated 65 million children between 3 and 18 years old in the US. That translates into a potential target patient population of only about 5,000-10,000 patients who may require therapy.
Pfizer confirmed that Ngenla will launch at a monthly list price of about $8,300 for a child weighing 35 kg. It is expected to become available starting in August. Distribution details were not disclosed.
Here is a recap of the now 14 various hGH products approved by the FDA:
Geref Diagnostic sermorelin 1990 Norditropin (Pro) somatropin 1995 Norditropin FlexPro somatropin 1995 Serostim (Pro) somatropin 1996 Saizen (Pro) somatropin 1996 Geref sermorelin 1997 Nutropin AQ (Pro) somatropin 1999 Genotropin (Pro) somatropin 2001 Zorbtive (Pro) somatropin 2003 Accretropin somatropin 2008 Zomacton somatropin 2015 Macrilen (Pro) macimorelin 2017 Skytrofa (Pro) lonapegsomatropin 2021 Sogroya (Pro) somapacitan-beco 2023 Ngenla somatrogon-ghla 2023
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FDA Approves Pfizer’s Ngenla, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency
June 28, 2023 — NEW YORK & MIAMI–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
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