Post-marketing Aduhelm trial planned for 2022
Amid doubts over its effectiveness, questions over the US Food and Drug Administration’s (FDA) decision to approve it initially and limited early take-up, further trials of the Alzheimer’s drug Aduhelm (aducanumab-avwa) are to take place next year.
US biotech company Biogen (Nasdaq: BIIB) and Japan’s Eisai (TYO: 4523) have confirmed the planned timeline for the Phase IV post-marketing confirmatory study.
"High level of priority being afforded to this study"The companies anticipate submitting the final protocol for review to the FDA in March 2022, with the initiation of patient screening in May 2022.
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