Pfizer PFE) and Opko Health (OPK) announced Friday that the Food and Drug Administration issued a Complete Response Letter for the Biologics License Application for somatrogon. Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of growth hormone deficiency in pediatric patients. Pfizer said it is ” evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward.” Added Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development: “We remain confident in the potential treatment benefits that somatrogon has to offer patients around the world. 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.” In 2014, Pfizer and Opko entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of growth hormone deficiency . Under the agreement, Opko is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product for GHD.
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