Roche CEO Schwan puts 3-time Alzheimer's loser gantenerumab back in the spotlight as FDA's controversial Aduhelm OK inspires blockbuster forecasts
Four years after Roche opted to resurrect its late-stage effort on their Alzheimer’s program for gantenerumab following a clear failure, Roche CEO Severin Schwan is signaling some fresh enthusiasm for its blockbuster prospects in the wake of the controversial Aduhelm OK.
Schwan told reporters that company execs are engaged in ongoing talks with the FDA as speculation continues to percolate around its chances based on biomarker data alone, now that regulators have established a precedent using an accelerated approval pathway process with no convincing evidence of efficacy in helping patients retain their cognitive skills. In Aduhelm’s case, the drug reduced the amount of amyloid in the brain and Biogen was able to win the accelerated approval on what the FDA called a reasonable expectation of success.
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