Allon Therapeutics announces davunetide receives FDA Fast Track Status for treatment of Progressive Supranuclear Palsy
Allon Therapeutics Inc. announced that its lead neuroprotective drug candidate, davunetide, has been granted Fast Track status from the United States food and Drug Administration (FDA) for the treatment of Progressive Supranuclear Palsy (PSP), a rapidly-progressing and fatal degenerative brain disease. Fast Track status is designed to facilitate development and expedite review of a drug candidate that treats a serious or life-threatening condition and addresses an unmet medical need.
Gordon McCauley, President and CEO of Allon, said the Fast Track status is an important milestone for the Company and validation of the desperate need for therapies in this debilitating disease where davunetide has such potential.
“Fast track status provides for early and frequent communication between the FDA and Allon to resolve questions and issues quickly,” said McCauley. “It will ensure that we work with the FDA to gather the critical data needed for approval.”
Fast Track also provides for “rolling submissions” in which sections of a new drug application (NDA) can be submitted and reviewed as they are completed rather than the typical process in which review begins only after the submission of the last section. Additionally, Allon may request that davunetide be considered for priority review, and if accepted would result in a six-month review instead of the standard ten-month review.
Allon announced January 12, 2010 that the FDA has granted Orphan Drug status to davunetide for the treatment of PSP treatment in the United States.
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