Pfizer and OPKO Health receives CRL, for somatrogon, from USFDA

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Pfizer and OPKO Health, on Friday, announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for Somatrogon. 

Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of growth hormone deficiency (GHD) in pediatric patients. Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward.

“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.”

Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development

Regulatory applications for somatrogon have already been submitted to several countries around the world for review and getting positive responses from many. Japan’s Ministry of Health, Labour and Welfare has approved NGENLA® (somatrogon) Injections for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone. 

NGENLA received the nod from Health Canada and  Australia’s Therapeutic Goods Administration (TGA) last year. Furthermore, in December 2021, the Committee for Medicinal Products for Human Use (CHMP) of EMA issued a positive opinion recommending somatrogon for marketing authorization in the European Union, to treat children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone. 

The initial biologic license application (BLA) for Somatrogon was accepted in January last year by FDA. In september 2021, the agency had extended the BLA for further review of three months. Meanwhile, the companies are waiting for a decision from the European Commission (EC), which is expected in early 2022.

Pfizer and OPKO, in 2014, entered into a worldwide agreement for the development and commercialization of Somatrogon for the treatment of GHD. Under the agreement, the latter is responsible for conducting the clinical program while the former is responsible for registering and commercializing the product for GHD.

Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone (somatropin) from the pituitary gland and affects one in approximately 4,000 to 10,000 children.

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