FDA Approves Additional Indication for Norditropin(R) for Small for Gestational Age (SGA) i...( Treatment Shown to Help Children ...)

Treatment Shown to Help Children Reach Normal Height

PRINCETON, N.J., Nov. 4 /PRNewswire-FirstCall/ -- 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(R) (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(R) 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(R), 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
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