On June 28, 2023, Pfizer Inc. and OPKO Inc. announced that their growth hormone NGENLA (somatrogon-ghla) has finally been approved by the US Food and Drugs Administration (FDA) for a once-a-week dosage to treat pediatric Growth Hormone Deficiency (GHD). Last year, the FDA approved NGENLA for marketing, however, they did not provide approval for usage.
Developed as a part of the Next Generation of Long-Acting Growth Hormone (LAGH), NGENLA is a human growth hormone analogue that is presented by the partnership of Pfizer Inc. and OPKO Inc. to treat GHD in pediatric patients of ages 3 and above. This LAGH can be administered once a week as a subcutaneous injection to pediatric patients of ages 3 and above that are suffering from GHD.
Compared to Pfizer’s previous once-daily growth hormone GENOTROPIN (somatropin), NGENLA offers a reduced dosage of once a week, which lessens the treatment burden.
“As a new, longer-acting option that has the ability to reduce treatment frequency from daily to weekly, NGENLA could become an important treatment option that can improve adherence for children being treated for growth hormone deficiency.” - Joel Steelman, Pediatric Endocrinologist, Cook Children’s Health Care System.
GHD is an uncommon disease and condition that is caused by the inadequate secretion of endogenous growth hormone. When left untreated, this can cause a lack of proper growth, delay puberty and lead to a short height in adulthood.
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In their partnership, OPKO Inc. has conducted the clinical program and development for NGENLA and Pfizer has handled the registration and commercialization for it.
Previously, NGENLA’s medical use was first approved in Canada in October 2021, followed by Australia in November 2021, Japan in January 2022, and the European Union in February 2022.
With FDA’s approval in June 2023, the US is the latest country to have approved this LAGH, which will enable the pediatric population suffering from GHD to reap its benefits.
“We are proud of the clinical development program that supported the FDA approval of NGENLA and are excited about its potential for these patients and their families as it becomes available in the United States.” - Phillip Frost, Chairman and Chief Executive Officer, OPKO Health.
NGENLA is approved in more than 40 markets, and it is anticipated that it will be released for medical prescription in the United States by August 2023.