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Pfizer's Genotropin (Somatropin [rDNA origin] for Injection) Approved in The U.S. for Treatment of Growth Failure Associated With Turner Syndrome

Estimated 60,000 girls and women in the United States suffer from a rare disease called Turner Syndrome with approximately 800 new cases diagnosed annually.

Pfizer Genotropin is the most prescribed growth hormone therapy worldwide. This announcement adds a fifth indication.

NEW YORK, N.Y. -- May 4, 2006 -- Pfizer Inc. announced today that the U. S. Food and Drug Administration (FDA) has approved a supplemental new drug application for Genotropin® (somatropin [rDNA origin] for injection) for the long-term treatment of growth failure associated with Turner Syndrome in patients whose bones are still capable of growing.

Turner Syndrome is a rare growth-related disorder affecting an estimated 60,000 girls and women in the United States with approximately 800 new cases diagnosed annually.

FDA approval was based on two randomized, open-label, clinical trials in 38 Turner Syndrome pediatric patients with short stature who were treated with Genotropin. During a 12-month treatment period, patients received Genotropin at a dose between 0.13 to 0.33 mg/kg/week.

Both studies demonstrated statistically significant growth increases from baseline height as measured by certain growth parameters. The growth response was greater in the study in which patients were treated with a larger dose of Genotropin. Generally, a dose of 0.33 mg/kg body weight/week is recommended in pediatric Turner Syndrome patients.

"Growth is one key indicator for good health, especially in early child development" said Michael P. Wajnrajch, MD, Medical Director, US Endocrine Care, Pfizer Global Pharmaceuticals. "We are pleased to now bring the benefits of Genotropin to this patient population. For more than 18 years, Genotropin has been used for growth-related disorders in more than 60,000 children worldwide."

Turner Syndrome, like a number of growth hormone-related disorders, is often called a rare or an orphan disease. Though affecting few people in number, available medical treatment to manage the condition is important to Turner Syndrome patients -- as there is no cure. Early diagnosis of short stature by a parent or pediatrician is essential for better patient outcomes and can help lead to better management of associated medical complications.

Aside from growth-related concerns, Turner Syndrome is also often associated with heart, kidney and/or thyroid problems. Turner Syndrome is typically diagnosed by an endocrinologist who will conduct blood tests to examine chromosomal composition and determine if one of the two X chromosomes found normally in females is missing or incomplete. Growth hormone treatment in Turner Syndrome patients with short stature can improve growth velocity.

In addition to Turner Syndrome, Genotropin has orphan-drug indications for other growth-related conditions including Small for Gestational Age (SGA) and Prader-Willi Syndrome, as well as being indicated for growth failure in children due to an inadequate secretion of endogenous growth hormone.

Important Safety Information:
• Growth hormone therapy should not be used in patients with cancer or who are receiving cancer treatment. It should not be used to increase height in children after the growth plates have closed. GH should also not be started in patients who are ill because of surgery, trauma, or respiratory failure. GH should not be used in patients with Prader-Willi syndrome who are severely overweight or have severe breathing problems.(1)
• Along with its benefits, any medical treatment may cause some unwanted effects. In studies of Genotropin in children with GHD, side effects include injection site reactions, such as pain, redness/swelling, inflammation, bleeding, scarring, lumps, or rash. Other side effects were fat loss, headache, blood in the urine, low thyroid activity, and mildly increased blood sugar. (2)
• In studies of Genotropin in children born SGA, side effects included temporarily elevated blood sugar, increased pressure in the brain, early puberty, abnormal jaw growth, injection site reactions, growth of moles, and worsening of scoliosis (curvature of the spine). This does not mean that your child will have any of these reactions. It's just that they are possible, based on reactions some children have had. (3)
• In studies of Genotropin in children with PWS, side effects included fluid retention, aggressiveness, joint and muscle pain, hair loss, headache, and increased pressure in the brain. (4)
• In two studies of Genotropin in pediatric patients with Turner Syndrome the most frequently reported adverse events were respiratory illnesses (influenza, tonsillitis, otitis, sinusitis), joint pain, and urinary tract infection. The only treatment-related adverse event that occurred in more that 1 patient was joint pain. (5)
• If the patient has diabetes, insulin dosage may need to be adjusted during therapy with Genotropin. (6)
• A higher incidence of slipped capital femoral epiphyses has been reported in pediatric patients with endocrine disorders. (7)
• Growth hormone should be used during pregnancy only if clearly needed. It should be used with caution in nursing mothers because it is not known whether GENTROPIN is present in human milk. (8)


REFERENCES:
1. Genotropin, Patient Summary of Information
2. Ibid
3. Ibid
4. Ibid
5. Genotropin, Prescribing Information
6. Genotropin, Patient Summary of Information
7. Genotropin, Prescribing Information
8. Genotropin, Patient Summary of Information


SOURCE: Pfizer Inc.

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