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The drug ALV003, a potentially promising treatment celiac disease, made by Alvine Pharmaceuticals, Inc., has received Fast Track designation from the U.S. Food and Drug Administration (FDA).
Celiac.com 10/15/2012 - The drug ALV003, a potentially promising treatment celiac disease, made by Alvine Pharmaceuticals, Inc., has received Fast Track designation from the U.S. Food and Drug Administration (FDA).
ALV003 is an orally administered mix of two recombinant gluten-specific proteases, a cysteine protease (EP-B2) and a prolyl endopeptidase (PEP).
ALV003 works by targeting gluten and breaking it down into tiny fragments, which, in tests has been show to greatly reduce its ability to trigger immune responded in people with celiac disease. ALV003 is being developed as a potential treatment for celiac disease patients in conjunction with a gluten-free diet and is currently in phase 2 clinical development.
The Fast Track status is important for ALV003, because there are currently no approved therapeutic treatment options available to patients and their physicians," said Abhay Joshi, Ph.D., Alvine's President and Chief Executive Officer.
Fast Track is part of the FDA Modernization Act, passed in 1997. It is designed to streamline the development and review of drugs that treat serious or life-threatening conditions, and which address unmet medical needs.