Yesterday, 1/31/24, Biogen announced that it will stop selling Aduhelm, its Alzheimer’s disease (AD) medication, by the end of this year. When initial approval was given by the Food and Drug Administration (FDA) to market this medication in 2021, FDA required Biogen to conduct additional studies to prove the efficacy of this new drug. Biogen announced yesterday that it is ending its study needed to obtain full approval from the FDA.
Readers may
remember reading my Personal Blog #23, posted on this site on 6/11/21 … “Letter
to Acting FDA Commissioner re Aduhelm.” In
the first paragraph of that PB #23 column, I wrote: “On 6/7/21, the FDA
approved the drug Aduhelm, Biogen’s aducanumab medication, an intravenous
infusion to be administered monthly for people with Alzheimer’s disease. Despite not one member of the FDA’s Advisory
panel voting to approve this med, FDA approved its use anyway. FDA determined that since Aduhelm helped
clear some amyloid protein from the brain, it may be “expected to help slow
dementia.” However, Biogen’s own data do
not support such a claim, and readers can read my Personal Blogs #11 and #12 to
learn more about results of clinical trials with this drug.”
I also wrote the following:
“For many patients and caregivers, the high costs of AD medications present an
economic hardship. Money spent on (ineffective) AD medications is money that
might otherwise be spent on day care programs, companions, home health aides,
or other services that would actually improve the quality of their lives.”
“I witnessed AD
spouse caregivers having to spend life savings on AD meds. Some had to
sell their homes when placing spouses in assisted living or to cover costs of
home health care aides. Now even more will have to do so because of money
needlessly spent on this latest bottle of hope you have approved. Based
upon data I have seen ... a difference of 0.39 on an 18 point scale of
cognitive and functional ability ... I can understand why not one member of
your 11 member Advisory panel of experts that evaluated the data for FDA voted
for approval.”
“I am SO sorry that
FDA has approved yet another costly "bottle of hope" that will now
financially ruin the lives of more AD spouse survivors with virtually zero
benefit to their loved ones. This is just not fair to people with AD, and
not fair to their eventually surviving spouses.”
I also shared an
email correspondence I had with Dr. Janet Woodcock, then acting FDA
Commissioner. In one email I had
written, “My gripe is that there is no clear
evidence that this med will actually slow cognitive decline in a meaningful
way. Unless and until Biogen can produce
clear evidence that their medication does slow cognitive decline to a
significant extent, it remains only an expensive bottle of hope.”
I
also quoted one of several members of the FDA Advisory panel who resigned from
the panel in protest, Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical
School. Kesselheim said that FDA’s
decision on Biogen “was probably the worst drug approval decision in recent
U.S. history … based on the debatable premise that the drug’s effect on brain
amyloid was likely to help patients with Alzheimer’s disease.”
In the last
paragraph of PB#23, I noted my final comment to acting FDA Commissioner Woodcock
re Aduhelm: “I want so much to see a new medication that will truly slow down
the progression of the disease to allow a longer period of quality of
life. I want so much to see development
of a new medication that will successfully treat if not cure AD. (But) When an Advisory FDA panel has 11
experts and not even one of those experts votes to approve this medication, one
has to wonder how something like this could happen.”
According to yesterday’s
report by The Associated Press (AP), about 2,500 people worldwide are currently
taking Aduhelm. The AP report further
stated, “Initially priced at $56,000 a year, analysts predicted it would
quickly become a blockbuster that would generate billions for Biogen. Medicare raised the premiums it charges for
its coverage partially because of an expected influx of Aduhelm claims. But doctors were hesitant to prescribe the IV
drug, given weak evidence that it meaningfully improved Alzheimer’s patients
lives.”
Although it comes
as no surprise to me, I am deeply saddened to see yet another much hyped potential
AD medication be declared a failure. I
have expressed my concerns about 2 other new AD meds targeting amyloid proteins
(plaques) in the brain in Personal Blogs #28, #31 and #32. These columns expressed my strong views on Lecanemab
(now marketed as Leqembi), and Donanemab, a med that the FDA is expected to consider
for approval within the next month or two.
Given Biogen’s
failure with Aduhelm, I can only reiterate what I wrote in last month’s PB #34. Until science discovers exactly what causes
AD … and as of today there is no definitive proof that AD is caused by the
build-up of amyloid proteins in the brain … it will be extremely difficult if
not impossible to develop a medication that can prevent AD or treat AD
effectively.
