Pfizer Japan Inc. and Opko Health, Inc. announced that the next generation long-acting growth hormone injection, Ngenla (somatrogon) Inj. 24 mg Pens and 60 mg Pens, has been approved by the Ministry of Health, Labour and Welfare (MHLW) in Japan.
Ngenla is a once-weekly long-acting recombinant human growth hormone, for the indication of short statue due to growth hormone deficiency without closed epiphyses. Ngenla provides patients with paediatric growth hormone deficiency (GHD) with a new option that reduces treatment frequency from daily injections to once-weekly injections.
This approval is based on the results of a phase 3 study conducted in Japanese subjects and a global phase 3 clinical study, both of which were conducted in subjects with paediatric GHD, and both of which compared the efficacy and safety of once-weekly Ngenla with Genotropin (somatropin), a recombinant human growth hormone for injection administered once-daily. In both studies, Ngenla showed comparable efficacy to Genotropin in the primary endpoint of annual height velocity at 12 months. Ngenla was generally well tolerated in both studies, with comparable safety to that of Genotropin administered once-daily with respect to the types, numbers and severity of the adverse events observed between the treatment arms.
