BSS
  11 Jun 2024, 10:41

US medical advisers vote to recommend Eli Lilly Alzheimer drug

WASHINGTON, June 11, 2024 (BSS/AFP) - An independent panel of US medical
experts voted Monday to recommend Eli Lilly's experimental Alzheimer's drug,
meaning there could soon be another treatment option available to patients
with the devastating brain disorder.

Donanemab was found in a trial carried out last year to slow cognitive
decline in the early stages of the disease -- but there was also a high rate
of side effects, including deaths.

The Food and Drug Administration (FDA) in March pushed back a planned meeting
of experts to evaluate the safety of the intravenously-injected antibody.

It normally follows its advisers recommendations, but is not required to do
so.

A green light would mean there is a second therapy that targets the
underlying causes of Alzheimer's, the most common form of dementia that
affects one in nine people over 65, progressively robbing them of their
memories and independence.

In Alzheimer's disease, two key proteins, tau and amyloid beta, build up into
tangles and plaques, known together as aggregates, which cause brain cells to
die and lead to brain shrinkage.

If approved, donanemab will be the third drug targeting amyloid beta to hit
the market. Biogen and Eisai launched the first, called Aduhelm, which was
controversially approved in 2021 despite concerns over its effectiveness, and
later withdrawn.

The same companies got another drug called Leqembi, which works in the same
way, approved last year.

Panelists in Monday's meeting were asked to consider whether donanemab should
be recommended widely, including among people with no or low levels of tau in
their brain, who were not included in the trial study.

In explaining their votes, several said the need to gather more data to
reduce scientific uncertainty should not prevent people from accessing and
benefiting from the medication in the short term.

They also found the benefits of the treatment outweighed the risks of people
in the early stages of the study, proposing ways to mitigate the risk of
brain bleeds by monitoring patients with MRI.

Eli Lilly stock was up 1.8 percent at the close of trading at $865.