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Japan’s MHLW Approves Pfizer and OPKO’s NGENLA® (Somatrogon), a New Long-Acting Treatment for Pediatric Growth Hormone Deficiency
NGENLA® offers a new once-weekly treatment option for children living with growth hormone deficiency TOKYO and MIAMI, Jan. 20, 2022 (GLOBE NEWSWIRE) -- Pfizer
About this update from Opko Health, Inc.
[{"type":"text","content":"NGENLA® offers a new once-weekly treatment option for children living with growth hormone deficiency\nTOKYO and MIAMI, Jan. 20, 2022 (GLOBE NEWSWIRE) -- Pfizer Japan Inc. and OPKO Health, Inc. (NASDAQ: OPK) announced today 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 pediatric 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 pediatric 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. “We are pleased to receive approval for once-weekly NGENLA®, which offers a new treatment option for pediatric GHD patients that can help reduce the burden associated with daily growth hormone administration. We wish to express our gratitude to the patients and their families who participated in the clinical studies and to all the sites conducting these trials,” said Taro Ishibashi, President of Pfizer R&D Japan G.K. In 2014, Pfizer and OPKO Health entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing somatrogon for GHD. 【About NGENLA】 Product nameNGENLA® Inj.24mg PensNGENLA® Inj.60mg PensGeneral nameSomatrogon (recombination)INDICATIONSShort stature due to growth hormone defi...