FDA issues complete response letter for pediatric GH deficiency treatment
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The FDA issued a complete response letter for somatrogon, an investigational treatment for pediatric patients with growth hormone deficiency, according to a press release from Pfizer and OPKO Health.
Pfizer is assessing the FDA’s comments on the once-weekly long-acting recombinant human GH and plans to collaborate with the agency to determine appropriate next steps, according to the release.
“We remain confident in the potential treatment benefits that somatrogon has to offer patients around the world,” Brenda Cooperstone, MD, chief development officer, rare disease, Pfizer global product development, said in the release. “We will work closely with the FDA to determine the best path forward to bring this important once-weekly treatment option to pediatric growth hormone deficiency patients and their families.”
Pfizer and OPKO Health have submitted regulatory applications for somatrogon around the world, such as in Japan, Canada and the European Union.
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