Shots:

• The marketing authorization was based on the P-III study to evaluate the safety & efficacy of Ngenla (qw) vs Genotropin (qd) in a ratio (1:1) in 224 prepubertal, treatment-naïve patients aged ≥3yrs. with GHD at ~20 countries
• The study met its 1EPs of non-inferiority as measured by annual height velocity @12mos., was well tolerated & had a safety profile, 95% of patients switched into the open-label extension study & received the treatment, improved the mean overall life interference total score @12wks.
• Ngenla is approved for pediatric GHD in Canada, Australia & Japan while the marketing authorization is valid in all EU Member States, Iceland, Norway & Liechtenstein

 Ref: Pfizer | Image: Pfizer