FDA Approves Norditropin For SGA In Children

Ruzanna Harutyunyan's picture

Children born with a condition that can prevent them from growing to a normal height now have a new treatment option available with the approval of Norditropin (somatropin [rDNA origin] injection) for the treatment of short stature in children born Small for Gestational Age (SGA) with no catch-up growth by age 2-4 years.

The U.S. Food and Drug Administration (FDA) approved Norditropin based on data from a 13-year clinical trial in children SGA. The study showed that 63 percent of children who reached adult height were in the normal range of their peers.

"Growth hormone therapy is the only treatment currently available to increase the height of a child with SGA," said Dianne Andrews, Executive Director of Major Aspects of Growth in Children (MAGIC) Foundation. "We are thrilled and supportive of a treatment option that may help these children achieve normal height and reduce the risk of physical and psychosocial problems associated with this condition."


Approximately 100,000 children in the U.S. are born annually with this condition. At birth, babies diagnosed SGA weigh less than approximately 97 percent of all other babies of the same gestational age. Some of these children will not catch up with the normal growth rates by the time they turn two.

"It is important for physicians to understand the potential for growth hormone treatment for children born SGA," said Dr. Robert Rapaport, Professor of Pediatrics, Emma Elizabeth Sullivan Professor of Pediatric Endocrinology and Diabetes, and Director of the Division of Pediatric Endocrinology and Diabetes at Mount Sinai School of Medicine. "The availability of Norditropin, a product with a 13-year study showing efficacy and safety in the treatment of SGA patients, offers an important additional treatment option for children born SGA."

Children diagnosed SGA may also be at increased risk of developing a number of long-term health consequences, including obesity, insulin resistance, carbohydrate intolerance, dyslipidemia, and psychosocial disadvantages. If untreated, SGA children account for nearly 15 percent of short adults.

In conjunction with this indication approval, and in support of the Novo Nordisk Triple Bottom Line; a commitment to economic success, environmental soundness, and social responsibility to employees and customers; the company will donate up to $15,000 to local charities in New Jersey, where the company has its U.S. headquarters.

"For 40 years, Novo Nordisk has helped to make children's lives better through an unwavering commitment to the field of endocrinology and growth-related disorders," said Eddie Williams, Vice President, Biopharmaceuticals, at Novo Nordisk. "In the past two years, Novo Nordisk has made Norditropin available to a wider range of patients through the approval of three indications: treatment of children with short stature associated with Noonan syndrome, treatment of children with short stature associated with Turner syndrome, and now, the treatment of patients born SGA."