The FDA has approved Increlex, Tercica's new drug for children who are experiencing difficulty in growing. About 6,000 children in the US suffer from extremely low levels of the IGF-1 hormone. Increlex adds an active ingredient similar to that hormone. In a 71-patient study over eight years, children taking the drug grew an extra inch compared to pre-treatment growth patterns.
"We are pleased Increlex was approved within the six-month priority review timeline, making Increlex the only therapy indicated to treat children with severe Primary IGFD," said John A. Scarlett, MD, CEO of Tercica. "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."
- read this story from the San Jose Mercury News for more