WESTON (dpa-AFX) - Biogen Inc. (BIIB) reportedly are 'reasonably confident' that the U.S. Food and Drug Administration will approve its experimental Alzheimer's drug.
According to CNBC, Biogen CEO Michel Vounatsos told that he is 'reasonably confident' of receiving approval from FDA for aducanumab, its experimental Alzheimer's drug.
'We worked in full transparency with the regulator,' Vounatsos told 'Squawk Box,' emphasizing the FDA has all of the company's data on the drug.
'The evidence came over time. We collected a tremendous and complex set of data, including biomarkers and imaging,' he said. 'This was a thorough engagement, and as CEO I'm reasonably confident this will lead to market approval one day.'
Shares of Biogen surged about 26% on Tuesday after the drugmaker announced plans to pursue regulatory approval for aducanumab, an investigational treatment for early Alzheimer's disease. The decision is based on a new analysis, conducted by Biogen in consultation with the FDA, of a larger dataset from the Phase 3 clinical studies that were discontinued in March 2019.
Biogen plans to file a Biologics License Application in early 2020. The company said it will continue dialogue with regulatory authorities including those in Europe and Japan.
Copyright RTT News/dpa-AFX
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