Vaxxinity vaccine to treat Alzheimer’s wins FDA fast-track designation

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Vaxxinity vaccine to treat Alzheimer’s wins FDA fast-track designation
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Multiple vaccines in the Dallas biotech company’s platform made significant regulatory progress in the last month.

The Food and Drug Administration gave Dallas-based Vaxxinity's vaccine candidate to treat Alzheimer's disease a fast track designation, Vaxxinity announced Monday.It’s been a promising month for Vaxxinity, the Dallas biotech company testing a new wave of vaccines to treat chronic diseases.

Following the mission of “democratizing health” by providing cheaper and more convenient therapies for chronic illnesses, Vaxxinity formed in 2021 with the combination of Covaxx of Dublin and United Neuroscience of Dallas. Now that UB-311 has the fast-track designation, Vaxxinity is eligible for more frequent communication with the FDA about data collection and proposed clinical trials. Such a label must be requested by the drug company and then reviewed by the FDA, according to the agency’s website.

UB-311 targets toxic forms of the amyloid beta peptide that accumulate as plaques in the brains of people with Alzheimer’s and is thought to contribute to the disease’s progression. The vaccine is one of several treatments aimed at amyloid beta currently competing for federal approval.

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