The FDA designates Alector’s (NASDAQ:ALEC) lead candidate AL001 for Fast Track review for the treatment of frontotemporal dementia (FTD), a group of brain disorders characterized by atrophy in the lobes of the brain in those areas.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
AL001 is an intravenously administered humanized recombinant monoclonal antibody designed to increase levels of a protein called progranulin in the brain. Mutations in the encoding gene can reduce granulin levels by as much as 70%. In these cases, the probability of developing FTD is greater than 90%.
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