Biogen CEO ‘reasonably confident’ once-doomed Alzheimer’s drug will be granted FDA approval

CNBC News

23 October 2019 - “This was a thorough engagement, and as CEO I’m reasonably confident this will lead to market approval one day,” says Biogen CEO Michel Vounatsos.

Biogen CEO Michel Vounatsos told CNBC on Wednesday that he is “reasonably confident” the Food and Drug Administration will approve the drugmaker’s experimental Alzheimer’s drug.

“We worked in full transparency with the regulator,” Vounatsos said on “Squawk Box,” emphasizing that 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.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine