Norditropin (somatropin[rDNA origin] injection) has been approved by FDA for treating short stature in children with Noonan syndrome, according to a recent statement by Novo Nordisk.
Noonan syndrome is classified as an autosomal dominant genetic syndrome that is commonly featured by congenital heart defects, short stature, and unique facial characteristics. It is believed that 80 percent of children suffering from Noonan syndrome tend to also suffer from considerable short stature.
From News.medical.net:
“When you see a child who has Noonan syndrome, it may not always be obvious to the naked eye, but the complications associated with the condition are quite serious and can affect both physical development and other systems” said Martin Soeters, president of Novo Nordisk Inc. “There are few treatment options available to help the physical development, and this approval marks an exciting advancement for children with this rare condition.”
Noonan syndrome is classified as a rare condition with a population of less than 200,000. To encourage the development of treatments for rare disorders — that may not otherwise be commercially viable for development — the FDA designates drugs that treat fewer than 200,000 patients with an “orphan drug” designation. Norditropin has received orphan drug designation for the treatment of short stature associated with Noonan syndrome.
It was remarked that careful monitoring is highly recommended when somatropin is administered in combination with other drugs that are known to be metabolized by CP450 liver enzymes such as sex steroids, corticosteroids, cyclosporine, and anticonvulsants.
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