Roche discussing potential Alzheimer’s treatment with FDA

pharmafile | July 22, 2021 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing  

Roche is discussing its potential treatment, gantenerumab, for Alzheimer’s disease with the FDA as clinical trials proceed.

Chief Executive Severin Schwan said Roche will complete a Phase-III trial of the medicine in the second half of next year.

He cited the urgency of finding a way to treat such an unmet medical need and bringing it to patients as soon as possible.

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.

Chief Executive Severin Schwan, said: “There is a continued dialogue with the FDA. I wouldn’t be able to speculate what the outcome of this dialogue will be.

“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.”

This news comes in the wake of the approval for Biogen’s Alzheimer’s drug, Adhuelm, which has sparked a lot of controversy.

There have been calls from a former FDA advisor, who resigned in protest of the drugs approval, to further investigate the FDA’s approval process.

Lilly Subbotin

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