PRINCETON, N.J., Sept. 21 Novo Nordisk todayannounced that Norditropin(R) (somatropin [rDNA origin] injection) receivedapproval from the U.S. Food and Drug Administration (FDA) for the treatment ofchildren with short stature associated with Turner syndrome. Turner syndromeis a rare chromosomal condition caused by complete or partial absence of thesecond sex chromosome (X chromosome) in females. This occurs in approximately1 in 2,500 live female births, and in as many as 10 percent of allmiscarriages worldwide. Short stature is the most common feature associatedwith Turner syndrome affecting the majority of patients (90 - 100 percentdepending on the chromosomal abnormalities).
"Treatment of short stature in girls with Turner syndrome is the secondnew indication granted this summer for Norditropin, which recently received anapproval to treat children with short stature associated with Noonansyndrome," said Martin Soeters, president of Novo Nordisk Inc. "Novo Nordiskis committed to our biopharmaceutical business unit, and we will continue toconduct research in rare disorders where there are currently treatment gaps."
This FDA approval signifies advancement in dosing capabilities, givingphysicians the option of dosing at higher than existing treatment options.Results from a pivotal clinical trial illustrated that treatment withNorditropin at the higher dosing level of .067 mg/kg/day resulted in 80percent of Turner syndrome patients reaching a normal adult height compared toonly 53 percent at a lower dosing level.
"I know first hand from my practice that short stature can be a social andself image concern for girls with Turner syndrome," said Judith Ross, M.D.,Professor, Department of Pediatrics at Thomas Jefferson University,Philadelphia. "Clinical data for Norditropin in girls with Turner syndromeshow for the first time that a higher dose Norditropin treatment regimenresults in growth to a height that is considered normal compared to thegeneral population. This higher dose option gives physicians more dosingflexibility and a greater chance of successfully treating short stature."
About Turner Syndrome
Turner syndrome is a rare chromosomal disorder of females characterized byshort stature and the lack of sexual development at puberty. Among affectedfemales, physical features may include a short neck with a webbed appearance,heart defects, kidney abnormalities and various other malformations. Severalmedical problems occur more frequently in individuals with Turner syndromethan in the general population, including a heightened incidence ofosteoporosis, cardiac malfunction diabetes and an increased risk of ear andhearing disorders. However, there is variability in the degree to which girlswith Turner syndrome are affected by any of its manifestations.
Clinical Features and Complications
Many characteristic features are associated with Turner syndrome. Theirpresence and severity vary greatly from individual to individual and caninclude
Norditropin(R) (somatropin [rDNA origin] injection) is indicated for thetreatment of children with short stature associated with Turner syndrome, thetreatment of children with short stature associated with Noonan syndrome, andtreatment of children with growth failure due to inadequate secretion ofendogenous growth hormone and for replacement of endogenous growth hormone inadults with growth hormone deficiency (GHD) who meet either of the followingtwo criteria:
In general, confirmation of the diagnosis of adult GHD in both groupsusually requires an appropriate growth hormone stimulation test.
Important Safety Information
Somatropin should not be used for growth promotion in pediatric patientswith closed epiphyses or in patients with active proliferative or severe non-proliferative diabetic retinopathy. Norditropin should no