Pfizer’s Ngenla Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency
Shots:
- The US FDA has approved Ngenla for the treatment of pediatric patients aged ≥3yrs. who have growth failure due to inadequate secretion of endogenous growth hormone. The therapy is expected to be available in the US in Aug 2023
- The approval was based on the P-III trial results evaluating the safety and efficacy of Ngenla (qw) vs somatropin (qd). The study met its 1EPs which showed that Ngenla was found to be non-inferior over somatropin as measured by annual height velocity at 12mos., was generally well tolerated & had a safety profile comparable to somatropin
- Ngenla was approved for the treatment of pediatric GHD in 40+ markets incl. Canada, Australia, Japan & EU member states
Ref: Pfizer | Image: Pfizer
Related News:- Pfizer and OPKO’s Ngenla (somatrogon) Receives EC’s Marketing Authorization for the Treatment of Pediatric Growth Hormone Deficiency
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