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Pharmaceutical industry

Genentech Submits New Drug Application for Nutropin to Treat Growth Failure in Turner Syndrome

Strategic Insights

— 1 min read

Genentech, a leading biotechnology company, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Nutropin, human growth hormone, to treat growth failure associated with Turner syndrome. This decision comes after a 12-year research effort and two long-term, multi-center clinical studies sponsored by Genentech, which have shown significant improvement in growth rate and adult height of girls with Turner syndrome treated with Nutropin.

Key Takeaways:

  • Genentech has submitted a New Drug Application (NDA) to the FDA for Nutropin to treat growth failure associated with Turner syndrome.
  • The NDA submission is based on two long-term, multi-center clinical studies sponsored by Genentech, which demonstrate improvement in growth rate and adult height of girls with Turner syndrome treated with Nutropin.
  • Turner syndrome is a genetic disorder in females caused by the loss of all or part of one X chromosome, resulting in short stature, lack of sexual development, and other symptoms.
  • Approximately 4,000 girls in the U.S. who suffer from short stature associated with Turner syndrome may be eligible for Nutropin therapy.
  • Genentech has already marketed two human growth hormone products in the U.S. and Canada: Protropin and Nutropin.
  • The Company has headquarters in South San Francisco and is traded on the New York and Pacific stock exchanges under the symbol GNE.

Statistics:

  • The average height of an untreated adult woman with Turner syndrome is 4 feet 8 inches.
  • Approximately 4,000 girls in the U.S. who suffer from short stature associated with Turner syndrome may be eligible for Nutropin therapy.
  • Genentech has a 12-year research effort behind the development of Nutropin.
  • Protoin and Nutropin are human growth hormone products marketed by Genentech in the U.S. and Canada.

Sources:

  • BUSINESS WIRE, October 4, 1995
  • "Genentech Submits New Drug Application for Nutropin to Treat Growth Failure in Turner Syndrome"

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