Alvine Pharmaceuticals' ALV003 is being developed as a treatment for celiac disease in conjunction with a gluten-free diet.
Alvine Pharmaceuticals, Inc. announced today that its lead candidate, ALV003, received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the potential treatment of patients with celiac disease. Alvine is currently conducting phase 2 clinical trials with ALV003.
"We are very pleased that the FDA has granted ALV003 this Fast Track designation. The decision reflects the seriousness of celiac disease and the potential of ALV003 to address the unmet medical needs of celiac disease patients. Currently there are no approved therapeutic treatment options available to patients and their physicians," said Abhay Joshi, Ph.D., Alvine's President and Chief Executive Officer. "Building on the data from our earlier phase 2A trial that demonstrated the ability of ALV003 to diminish gluten-induced intestinal injury in well-controlled celiac disease patients, we look forward to pursuing phase 2 and phase 3 trials under the Fast Track program."
Under the FDA Modernization Act of 1997, the Fast Track program was designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA during clinical development and for the possibility of priority review, which can reduce the time required for FDA review of a New Drug Application.
ALV003 is an orally administered drug that targets gluten and degrades it into small fragments, which, in vitro, diminishes its immunogenicity. 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.
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