A biologic drug developed by Pfizer could provide easier drug delivery for children with growth hormone deficiency Refuse Provided by FDA.
Pfizer disclosed the regulatory action late Friday. The FDA’s full response letter is not a public document, and the company did not say what concerns or questions the agency had raised about the drug somatrogon. Pfizer said only that it is evaluating the FDA’s comments and will work with the agency to determine the direction of the drug.
growth hormone deficiency is a rare disease that affects children and adults. In children, the condition can cause growth and development problems. Growth hormone deficiency in adults can lead to increased fat and decreased muscle mass, as well as high cholesterol levels. Genetic mutations can cause growth hormone deficiency; when it is acquired, the cause may be related to trauma, infection, radiation therapy, or tumors in the brain. In some cases, there is no known cause.
Deficiency is treated with injections of human growth hormone, usually given daily. Pfizer is already selling such a product, Genotropin, which generated $427 million in revenue in 2020. Somatrogon is a human growth hormone designed to provide long-acting action, allowing weekly dosing. This medication is administered through a prefilled injection pen. In the stage 3 test for children, somatrogon achieved the main goal As assessed by measuring the rate of height growth at 12 months, it was not inferior to daily injections of Genotropin. Somatrogon was well tolerated by patients in the clinical trial, and adverse events reported in the clinical trial were comparable between the two groups.
Patients already have a new option for weekly human growth hormone injections. last August, FDA approves Skytrofa, developed by Ascendis Pharma in Copenhagen, Denmark. The regulatory decision made the product the first once-weekly product approved for the treatment of growth hormone deficiency in children. 13 January, European regulators officially recognized The indications for the Ascendis drug are the same. Pivotal pediatric clinical trials are underway in Japan and China. Additionally, a global Phase 3 study is evaluating Skytrofa as a treatment for growth hormone deficiency in adults.
Pfizer Get global rights In a 2014 deal, Somatrogon paid Opko Health $295 million. Another $275 million is tied to regulatory milestones, and the deal also enables Opko to receive royalties and a portion of profits from product sales. Under the terms of the agreement, Opko is responsible for clinical development of the drug, while Pfizer is responsible for regulatory and commercialization efforts, including manufacturing.
Although the complete response letter to somatrogon is a setback, Pfizer is pushing ahead with commercialization and regulatory applications in other markets. The drug is approved in Japan and sold under the name Ngenla. It is also approved for use in Canada and Australia. A regulatory decision in Europe is expected early this year.
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