The approval is based on Ngenla’s showing non-inferiority to PFE’s daily Genotropin. Genotropin had annualized worldwide sales of ~$600M in 1Q23, despite competition from ASND’s Skytrofa (#msg-165622237).
The Ngenla BLA received a CRL in Jan 2022 for undisclosed reasons (#msg-167595039). PFE and OPK inked a partnership deal for commercial development of hGH in 2014 (#msg-109075402).