US biotech major Biogen’s (Nasdaq: BIIB) decision to resurrect the development of its previously-failed Alzheimer’s disease (AD) candidate aducanumab and move on with a regulatory filing came as a big revelation to industry watchers.
Adding to the chorus of comments, Alessio Brunello, senior pharma analyst at GlobalData, said: “The revaluation of aducanumab by Biogen has come as a surprise as the data published last spring were very disappointing and there was no statistical efficacy shown in the results. However, if these new data are confirmed, aducanumab will represent the first monoclonal antibody (MAb) to demonstrate a statistically-significant reduction in amyloid plaque and slowing of cognitive impairment in patients with prodromal or mild AD.
“The AD pipeline has been characterized by big failures as AD drug development is considered to have one of the highest failure rates of all indications. The AD pipeline features 117 drugs across all stages of development in the *7MM (USA, 5EU and Japan), and only 12% of these are in late-stage development. According to GlobalData, the Amyloid precursor protein (Aβ peptide and protein), the microtubule associated protein tau (MAPT), and Beta Secretase1 inhibitors (BACE1) are the major targets being pursued by companies developing drugs against AD.
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