INSMED SUBMITS NDA FOR SOMATOKINE TO TREAT GROWTH HORMONE INSENSITIVITY SYNDROME

Insmed has submitted a new drug application to the FDA for regulatory approval of SomatoKine for the treatment of growth hormone insensitivity syndrome.

The application includes safety and efficacy results from Insmed's prospective, multicenter, Phase III clinical trial with SomatoKine (mecasermin rinfabate) conducted in patients with growth hormone insensitivity syndrome. SomatoKine is Insmed's proprietary insulin-like growth factor-I (IGF-I) therapy, composed of recombinant human IGF-I and IGF binding protein 3.