Wednesday, September 22, 2021

Roche in talks with FDA on Alzheimer’s candidate, says CEO

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ZURICH (Reuters) – Swiss drugmaker Roche is discussing its potential treatment for Alzheimer’s disease with the U.S. Food and Drug Administration (FDA) as clinical trials proceed, Chief Executive Severin Schwan told reporters on Thursday.

Analysts have speculated about an expedited filing for regulatory approval of gantenerumab, which could be a blockbuster if shown to work against the debilitating disease.

Roche will complete a Phase-III trial of the medicine in the second half of next year, Schwan said, citing the urgency of finding a way to treat such an unmet medical need and bringing it to patients as soon as possible.

“There is a continued dialogue with the FDA. I wouldn’t be able to speculate what the outcome of this dialogue will be,” he said.

“Our trial is a well-designed, very comprehensive trial so, whatever the outcome of this trial will be, we will have a definitive answer of what we can do for patients with this terrible disease so let’s keep fingers crossed,” he added.

(Reporting by Michael Shields; Editing by Edmund Blair)


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