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news.The FDA has approved Tercica's drug, Increlex, for the long-term treatment of growth failure in children. The product was also given orphan drug status for severe primary IGFD deficiency, a condition that leads to growth failure.
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The drug, acquired by Tercica from Genentech, is specifically approved for children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone.
Insulin-like growth factor-1, or IGF-1, is the direct mediator of growth hormone’s effect on statural growth and must be present in order for children’s bones, cartilage, and organs to grow normally. Severe Primary IGFD is a growth hormone-resistant state characterized by abnormally low blood IGF-1 levels in the presence of normal or elevated growth hormone, which afflicts approximately 6,000 children in the US.
“Today, Increlex becomes Tercica’s first commercial drug and represents the first major innovation in the treatment of short stature since recombinant growth hormone was approved 20 years ago — an advance that we believe will change the way physicians diagnose and treat patients with growth failure due to severe Primary IGFD,” said Dr John Scarlett, president and CEO of Tercica.
The active ingredient of Increlex is identical to the natural hormone, IGF-1, which the body produces in response to stimulation by growth hormone. Without adequate IGF-1, children cannot achieve height within the normal range.