New Clinical Results — Mea Culpa?

AFAIK Dispatch #11

Alzheimer’s Families for Action, Innovation and Knowledge

I would like to believe that I’ve been wrong. There are positive clinical results from another drug, donanemab, joining Leqembi (which has already had expedited FDA approval.) Results below. My ongoing concerns are the pressure on the FDA to release something, anything, that might halt or reverse cognitive decline — results below include significant side effects. The other is the potential impact on Medicare premiums if these drugs become widespread at high cost, as we already saw even in the case of a premature FDA approval (Aduhelm).

Donanemab clinical results — “top-line results showed that in the primary analysis population of 1182 patients with clinical symptoms and an intermediate level of tau, donanemab led to a 35% slowing of decline compared to placebo over 18 months on the integrated Alzheimer’s Disease Rating Scale (iADRS), a composite tool devised by Eli Lilly to capture cognitive and functional worsening. Awaiting FDA approval in July, which would make it the second such approval, after Leqembi.

Alzheimer’s researchers hailed the news. “The donanemab Phase 3 trial is a major accomplishment on many levels,” wrote David Knopman, Mayo Clinic, Rochester Minnesota…Eric Siemers at Siemers Integration LLC, previously at Lilly, pointed out the consistency of findings between donanemab, lecanemab, and aducanumab. “Given these results, it can no longer be said that we have no treatments to slow the inexorable progression of AD,” he wrote. Indeed, the amyloid hypothesis is no longer a hypothesis, wrote Dennis Selkoe at Brigham and Women’s Hospital, Boston.” I’m not sure why aducanumab (Aduhelm) is lumped into this comparison, when its efficacy was limited to only 1 of 2 trials, leading to its ultimate abandonment by its developer.

Investor response — “data release Wednesday of Eli Lilly’s donanemab drew enthusiastic reaction from investors, with company shares climbing nearly 7% on news that the anti-amyloid therapy slowed Alzheimer’s disease progression by about a third compared to placebo over 18 months.”

As always, another cautionary note here about our privatized, share price-driven health care system.

Mea culpa? All news considered, not yet.