Latebreakers: New indication for Norditropin

October 8, 2007

Somatropin (Norditropin, Novo Nordisk) approved by FDA for Turner syndrome

Somatropin (rDNA origin) injection (Norditropin, Novo Nordisk) can now be used for the treatment of children with short stature associated with Turner syndrome, a condition caused by a complete or partial absence of the second X chromosome in females. Earlier this year, the drug was approved for treating short stature related to Noonan syndrome and is also indicated for the treatment of children with inadequate secretion of endogenous growth hormone and for replacement of the hormone in adults with growth hormone deficiency meeting certain criteria. The new approval also gives the option of dosing somatropin at a higher dosage level. In a clinical trial, the higher dosage resulted in 80% of Turner syndrome patients reaching their normal height versus only 53% who were dosed at a lower level.