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Pharmaceutical industry

FDA Accepts Filing for Exubera, a Novel Inhaled Insulin Product

Strategic Insights

— 1 min read

Diabetes has become a major public health issue, affecting nearly 180 million people worldwide, with the number expected to rise to 300 million in the next 20 years. Currently, diabetes and its complications account for more than $100 billion in healthcare costs annually in the United States. To address this growing concern, Pfizer and Sanofi-Aventis have collaborated to develop Exubera, an inhaled human insulin powder that can be administered via a specially designed inhalation device. This innovative product has undergone extensive clinical trials, with over 3,500 patients participating, some for more than 7 years.

Key Takeaways:

  • Exubera, a dry powder form of insulin, is expected to be a breakthrough treatment for patients with diabetes, offering a new delivery method for administering insulin.
  • The FDA has accepted for filing a new drug application for Exubera, marking an important milestone in the development of this innovative product.
  • Exubera has been studied in over 3,500 patients, with some participants undergoing treatment for more than 7 years.
  • The product has the potential to improve treatment outcomes for millions of patients worldwide, as it offers a more convenient and understandable form of insulin administration.
  • Exubera is currently under review by the European Medicines Evaluation Agency, in addition to the FDA.
  • Diabetes and its complications account for over $100 billion in healthcare costs annually in the United States, highlighting the need for innovative treatments like Exubera.
  • Nektar Therapeutics, the developer of the inhalation device and powdered insulin for Exubera, has a long-standing collaboration with Pfizer and Sanofi-Aventis to co-develop and co-promote inhaled insulin.

Statistics:

  • Over 180 million people worldwide suffer from diabetes.
  • The number of people with diabetes is expected to rise to 300 million in the next 20 years.
  • Diabetes and its complications account for over $100 billion in healthcare costs annually in the United States.
  • Exubera has undergone clinical trials involving over 3,500 patients.
  • Some patients in the clinical trials underwent treatment for more than 7 years.

Sources:

  • Health & Medicine Week editors via NewsRx.com (2005)
  • Nektar Therapeutics
  • Pfizer Inc
  • The Sanofi-Aventis Group
  • U.S. Food and Drug Administration (FDA)

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