Shots:

• The BLA submission is based on P-lll study assessing the safety and efficacy of Somatrogon (0.66 mg/kg- qw) vs Somatropin (0.034 mg/kg- qd) in 224 pediatric patients in the ratio of (1:1) with GHD
• The study met its 1EPs of non-inferiority as measured by annual height velocity @12mos.; least square mean (10.12 vs 9.78 cm/year); the treatment difference in height velocity was 0.33 cm/yr
• The anticipated PDUFA date is Oct 2021 and is approved- the therapy is served as a once-weekly treatment option

 ­ Ref: Business Wire | Image: The Wire