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European Union Grants New Indication for Pfizer's Genotropin NEW YORK, NY -- July 4, 2003 -- Pfizer Inc announced today that the European Agency for Evaluation of Medicinal Products (EMEA) has approved Genotropin(R) (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. About Genotropin In July 2001, the Food and Drug Administration approved Genotropin (somatropin [rDNA origin] for injection) in the United States for the long-term treatment of growth failure in children who were born SGA who do not achieve catch-up growth by age two. Other causes of short stature in pediatric patients should be excluded. The FDA granted Genotropin Orphan Drug Status, making it the only growth hormone approved in the United States for the condition at a recommended dose of 0.48 mg/kg body weight/week. Growth hormone should not be used in patients with any evidence of neoplastic activity or receiving antitumor therapy. Growth hormone should not be used for growth promotion in children with fused epiphyses. Growth hormone should not be initiated to treat patients with acute critical illness due to complications from surgery, trauma or respiratory failure; the safety of continuing growth hormone treatment for approved uses in patients who develop acute critical illness has not been established. The 5.8-mg and 13.8-mg cartridges of Genotropin Lyophilized Powder contain m-Cresol and should not be used by patients with a known sensitivity to this preservative. Genotropin (at 0.48 mg/kg body weight/week dose) is generally well tolerated. In clinical studies of 273 patients born SGA treated with Genotropin, the most commonly reported adverse events included: mild transient hyperglycemia, one patient with benign intracranial hypertension, two patients with central precocious puberty, two patients with jaw prominence, and several patients with aggravation of pre-existing scoliosis, injection site reactions, and self- limited progression of pigmented nevi. SOURCE: Pfizer Inc E-mail this page to a friend or colleague! To print, use this version