Whether certain groups of early Alzheimer’s patients are more likely than others to benefit from investigational donanemab is a key question FDA advisors will try to untangle when they meet on June 10.
In briefing documents released ahead of next Monday’s meeting of the agency’s advisory committee, FDA staffers questioned whether tau levels should play a role in determining who might qualify for donanemab treatment, if the drug is eventually approved.
The Peripheral and Central Nervous System Drugs will discuss whether the benefits of donanemab outweigh its risks for people with early Alzheimer’s disease. If approved, donanemab will be the third amyloid-targeted drug to come to market: the first being the controversial aducanumab (Aduhelm), which received accelerated approval but was subsequently abandoned, and the second being lecanemab (Leqembi), which received full FDA approval last year.
Donanemab, which targets a modified form of beta amyloid known as N3pG, was tested in the phase III TRAILBLAZER-ALZ 2 trial (referred to as Study AACI in the FDA’s briefing documents) of 1,736 early Alzheimer’s patients.
The drug met the primary endpoint of change from baseline in the Integrated Alzheimer’s Disease Rating Scale (iADRS), slowing decline relative to placebo. At 76 weeks, mean change on the iADRS was -10.19 in the donanemab group versus -13.11 in the placebo group for all participants in the study (P
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