FDA grants fast track designation for Alzheimer’s treatment
The FDA has granted fast track designation for Vaxxinity Inc.’s UB-311, an anti-amyloid beta immunotherapeutic vaccine, for the treatment of Alzheimer’s disease.
UB-311 is an immunotherapeutic vaccine candidate, which targets toxic forms of amyloid beta in the brain, in order to treat Alzheimer’s disease. Phase 1, phase 2 and phase 2a long-term extension trials have shown UB-311 to be well-tolerated and safe in patients over 3 years of repeat dosing.
“We are excited that the FDA has granted UB-311 fast track designation, as it recognizes the evidence demonstrating the potential for UB-311 to address a serious unmet medical need for patients with Alzheimer’s disease,” Vaxxinity CEO Mei Mei Hu, said in a released statement from the company.
According to the release, FDA’s fast track program is designed to facilitate the development and expedite the review of new drugs intended to treat serious or life-threatening conditions. A fast track designation allows frequent engagement with the FDA, in order to discuss developmental plans and design of proposed clinical trials.
“We are on an encouraging clinical path for UB-311 and look forward to collaborating with the FDA and other global regulatory agencies to bring UB-311 expeditiously to the global market,” Hu said. “Because our vaccine approach allows for more convenient administration and broad access, UB-311 is positioned to potentially lead a paradigm shift in the treatment, and even prevention, of Alzheimer’s.”