Once-Weekly Pediatric Growth Hormone Snags FDA Approval
Somatrogon injection given go-ahead after initial FDA rejection last year
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Somatrogon injection given go-ahead after initial FDA rejection last year
Somatrogon-ghla (Ngenla; Pfizer Inc, OPKO Health Inc) is a subcutaneous injection that is administered once weekly via a device allowing for titration based on patients’ needs.
New, longer-acting treatment offers option to reduce the frequency of injections for children with growth hormone deficiency from daily to once-weekly
Ngenla, a hormone drug from partners Pfizer and Opko Health, is now FDA approved for treating children with growth hormone deficiency. The once-weekly injectable biologic will compete against an Ascendis Pharma product that won its FDA approval in 2021.