Roche is discussing Alzheimer’s drug with FDA following regulators controversial approval of Biogen’s Aduhelm, CEO says


22 July 2021 - Roche is discussing its potential Alzheimer’s treatment with the U.S. FDA, CEO Severin Schwan said Thursday, the latest pharmaceutical company to court the regulator following its controversial fast track approval of Biogen’s Aduhelm.

Gantenerumab, a potential blockbuster if approved, is still being tested in clinical trials, with a large scale Phase 3 trial set to finish in the second half of 2022, Schwan said.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation