Biotech | December 24, 2021
Lecanemab granted Fast Track designation by the U.S. FDA
Alzheimer's disease is a serious, progressive and devastating disease with few treatment options
Alzheimer's disease is a serious, progressive and devastating disease with few treatment options
Alnylam is the latest partner in the Medicines Manufacturing Innovation Centre’s third Grand Challenge project, which aims to revolutionise the manufacturing process for oligonucleotide therapies
The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology
This multi-centre study (sites in the US and Europe) comprising about 387 patients is likely to be completed in about 36 months and the topline result is expected by the end of 2024
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