Pfizer Inc announced that the European Agency for Evaluation of Medicinal Products (EMEA) has approved Genotropin (somatropin [rDNA origin] for injection) for the treatment of growth disturbance in short children born small for gestational age (SGA) who failed to show catch-up growth by four years of age or later. The approval applies to all 15 member states of the European Union.

"Because not all children who are born SGA will experience catch-up growth, it's important for doctors and parents to realize that children who don't approach the normal height range by age four are unlikely to reach it later in childhood," said Dr. Pierre Chatelain, Pfizer Vice President, Global Medical Endocrinology. "These children will likely remain small -- even as adults -- and deserve prompt diagnosis and appropriate treatment. Approval of Genotropin for growth disturbance in children born SGA is only a meaningful advance if children are diagnosed and treated appropriately."

Children born SGA are more than two standard deviations below the mean for birth weight and/or height (less than the third percentile) for their gestational age. In full-term babies, this is roughly equivalent to a birth weight less than 5 lbs 6 ounces and/or 18 inches in length. While the majority of these children "catch up" to normal height by the time they are two years old, as many as 10 percent do not. These children may not reach their growth potential and may remain short in stature throughout life.