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Related Experiment Videos

Pramlintide (Amylin).

D Barlocco1

  • 1University of Milan, 1st Chimo Farmaceutico/Tossicologico, Italy. daniela.barlocco@unimi.it

Current Opinion in Investigational Drugs (London, England : 2000)
|January 5, 2002
PubMed
Summary
This summary is machine-generated.

Pramlintide, an amylin analog, is being developed as a diabetes treatment. Regulatory submissions are underway in the US and Europe for its use in type 1 and type 2 diabetes.

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Area of Science:

  • Endocrinology
  • Pharmacology

Background:

  • Pramlintide is a synthetic analog of human amylin.
  • It is being developed for diabetes management.

Purpose of the Study:

  • To evaluate pramlintide as an adjunct therapy with insulin for type 1 and type 2 diabetes.
  • To seek regulatory approval for marketing pramlintide.

Main Methods:

  • Submission of a US New Drug Application (NDA) to the FDA.
  • Submission of a Marketing Authorisation Application (MAA) to the EMEA.
  • Review by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee.

Main Results:

  • Amylin received an approvable letter from the FDA for both type 1 and insulin-using type 2 diabetes.
  • Discussions with the FDA are ongoing regarding required clinical work for NDA approval.
  • Conclusions:

    • Pramlintide shows potential for managing type 1 and type 2 diabetes.
    • Further clinical evaluation is required for full FDA approval.