FDA Approves Sogroya, a Once-Weekly Growth Hormone Deficiency Therapy
Brian Park, PharmD
Sept. 2, 2020 (MPR) — The Food and Drug Administration (FDA) has approved Sogroya® (somapacitan-beco; Novo Nordisk) injection for the replacement of endogenous growth hormone in adults with growth hormone deficiency.
Sogroya, a human growth hormone analogue, is administered by subcutaneous injection one time each week. The approval was based on data from the multicenter, double-blind, placebo-controlled, active-controlled phase 3 REAL 1 trial that evaluated the efficacy and safety of Sogroya in 300 adults with growth hormone deficiency who were treatment-naïve or had discontinued other growth hormone formulations for ≥3 months.
Patients were randomized 2:1:2 to receive once weekly injections of Sogroya or placebo, or daily somatropin for 34 weeks. The primary end point was the change in truncal fat percentage from baseline to week 34.
Results showed that patients treated with Sogroya demonstrated a mean reduction of 1.06% in truncal fat at week 34 compared with an increase of 0.47% for placebo (absolute treatment difference of -1.53%; 95% CI: -2.68, -0.38; P =.009). Patients treated with daily somatropin achieved a change in truncal fat % of -2.23% after 34 weeks.
Similar improvements in other clinical end points, including normalized insulin-like growth factor (IGF-I) standard deviation scores at week 34, were observed in the Sogroya and somatropin treatment arms.
The most common adverse reactions associated with Sogroya treatment included back pain, arthralgia, dyspepsia, sleep disorder, dizziness, tonsillitis, peripheral edema, vomiting, adrenal insufficiency, hypertension, increased blood creatine phosphokinase, increased weight, and anemia.
Sogroya is supplied as 10mg of somapacitan-beco in 1.5mL single-patient-use prefilled pens.
For more information visit novonordisk-us.com.
References
- FDA approves weekly therapy for adult growth hormone deficiency. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-weekly-therapy-adult-growth-hormone-deficiency. Accessed September 2, 2020.
- FDA approves once-weekly Sogroya® for the treatment of adult growth hormone deficiency. https://www.novonordisk-us.com/media/news-releases.html?122995. Accessed September 2, 2020.
- Sogroya [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2020.