CANGENE RECEIVES AN APPROVABLE LETTER FOR GROWTH HORMONE
Cangene said it has received an approvable letter from the FDA for its application for Accretropin, the company's recombinant human growth hormone. The drug has been developed as a treatment of growth failure in children with growth hormone deficiency and short stature associated with Turner Syndrome.
This is the first recombinant product for which Cangene has submitted an application to the FDA. The company filed the application in July 2006. Accretropin was developed under a research and development agreement with the Apotex, Cangene's majority shareholder.
Cangene's recombinant human growth hormone is identical in sequence to naturally produced human growth hormone. Natural human growth hormone is a protein produced by the pituitary gland that acts on the long bones of the body until the onset of puberty and promotes growth to normal stature. A deficiency of this hormone during childhood results in abnormally small stature.