New Human Growth Hormone Approved For Adults

[~MaryO~]

A New Indication for Norditropin® (somatropin rDNA injection)

 

.c The Associated Press

 

Novo Nordisk's Human Growth Hormone Now Approved for Use in Adults

 

PRINCETON, NJ (Market Wire) - (http://www.novonordisk-us.com) http://media.marketwire.com/attachments/20...4324-Novonordis logoSmall.jpg

 

Novo Nordisk (NYSE: NVO) today announced that the Food and Drug Administration (FDA) has approved the use of Norditropin@ (somatropin rDNA injection) in adults with severe growth hormone deficiency. Norditropin was approved by the FDA in 1997 for use in children.

 

Today's action by the FDA makes it possible for children being treated with Norditropin for growth hormone deficiency to continue their treatment into adulthood, and also allows for the treatment of adults with conditions that result in a deficiency of growth hormone. Earlier this year the FDA approved Novo Nordisk's Norditropin NordiFlex@, the first prefilled, multidose, disposable growth hormone pen in the United States.

 

``We are dedicated to meeting the needs of individuals who require growth hormone therapy treatment,'' said Michael Shalmi, M.D., vice president of biopharmaceuticals, Novo Nordisk Pharmaceuticals, Inc. ``This approval by the FDA is yet another step in Novo Nordisk's proud history of innovation in the field of growth hormone therapy.''

 

Growth Hormone Deficiency in Adults

 

GH deficiency in adults is a clinical syndrome that usually results from a pituitary or peri-pituitary tumor or as a direct result of the surgery or radiation used to treat the tumor. GH deficiency also occurs from other pituitary-related disease or from a deficiency in childhood(1). The prevalence rate of adults with GH is approximately two in 10,000 of the adult population, with adult-onset GH accounting for approximately one in 10,000(2).

 

About Norditropin

 

Norditropin from Novo Nordisk is human growth hormone that has been biosynthetically produced to resemble growth hormone the body makes naturally. It is essentially identical to natural growth hormone in composition.

 

Novo Nordisk first produced biosynthetic growth hormone in 1985. In 1999, the company introduced a liquid growth hormone formulation that did not require a reconstitution or mixing procedure before injection. This was a major advance in simplifying growth hormone therapy for patients.

 

Norditropin is indicated for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone and for replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD) who meet either of the following two criteria: 1. Adult Onset (AO): Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or 2. Childhood Onset (CO): Patients who were growth hormone deficient during childhood should have GHD confirmed as an adult before replacement therapy with Norditropin is started. GHD should be confirmed by an appropriate GH stimulation test.

 

Norditropin should not be used in patients with known hypersensitivity to somatropin or any of its excipients, in patients with proliferative or preproliferative diabetic retinopathy. Growth hormone (GH) should not be used in patients with active neoplasia and should be discontinued if evidence of neoplasia develops. Growth hormone (GH) should not be used in pediatric patients with closed epiphyses.

 

Increased mortality may occur in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure.

 

Deaths have been reported in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Male patients with one or more of these factors may be at greater risk than females. Unless patients with Prader-Willi syndrome also have a diagnosis of GHD, Norditropin is not indicated for the long-term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

 

Funduscopic examination of patients is recommended at the initiation and periodically during the course of growth hormone therapy.

 

Monitor patients with GHD secondary to an intracranial lesion for progression or recurrence of the underlying disease process. Monitor patients with glucose intolerance closely; insulin dosage may need to be adjusted. Monitor carefully if GH is administered in combination with other drugs metabolized by the CP450 pathway. Patients with coexisting ACTH deficiency should have their glucocorticoid replacement dose carefully adjusted to avoid an inhibitory effect on growth. Periodically monitor bone age in pediatric patients, especially in patients who are pubertal and/or receiving concomitant thyroid hormone replacement therapy.

 

Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea and/or vomiting has been reported in a small number of patients treated with growth hormone products.

 

As with all protein drugs, a small percentage of patients may develop antibodies to the protein. Since antibodies to somatropin have the potential to inhibit further linear growth, only patients failing to respond to treatment should be tested for antibodies.

 

The following adverse events have been reported during clinical studies in growth hormone deficient children: headache, local reactions at the injection site, localized muscle pain, rash, weakness, mild hyperglycemia, glucosuria and arthralgia. Fluid retention and peripheral edema may occur.

 

In clinical studies with Norditropin in GHD adults the majority of side effects were symptoms of fluid retention including peripheral edema, arthralgia, myalgia, infection (non-viral) and parasthesia. In general, these side effects were mild and transient in nature.

 

Full prescribing information for Norditropin@ and Norditropin NordiFlex@ is available by contacting Novo Nordisk Pharmaceuticals, Inc. or visiting (http://www.norditropin.com) www.norditropin.com.

 

Norditropin and Norditropin NordiFlex are registered trademarks of Novo Nordisk A/S.

 

Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy and hormone therapy for women. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 20,000 full-time employees in 69 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO.' For more information, visit novonordisk.com, or in the US, (http://www.novonordisk-us.com) www.novonordisk-us.com.

 

(1) American Association of Clinical Endocrinologists medical guidelines for clinical practice for growth hormone use in adults and children 2003 update. Endocrine Practice. Vol 9 No. 1 January/February 2003.

 

(2) Bryan J, Loveman E, Chase D, Mihaylova B, Cave C, Gerard K, Milne R. Clinical effectiveness and cost-effectiveness of growth hormone in adults in relation to impact on quality of life: a systematic review and economic evaluation. Health Technology Assessment NHS R&D HTA Programme. 2002; Vol. 6:No.19

 

For further information please contact: Media: Susan Jackson 609-919-7776 Investors: Christian Kanstrup 609-919-7937

 

Copyright © 2004 Market Wire

 

Distributed by the Associated Press

 

 

 

11/04/04 13:10 EST

 

 

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[KathiK]

Very interesting - thanks!