FDA Approves Alzheimer’s Drug Lecanemab Amid Safety Concerns

Food and Drug Administration on Friday approved a treatment for Alzheimer's that has been
shown in clinical trials to decrease cognitive loss in patients with the disease's early stages.

Even though there have been reports of adverse effects with the new medicine, doctors say
the approval offers patients renewed hope following repeated failures to develop successful
treatments.

What is Lecanemab?

Lecanemab, a monoclonal antibody infusion that will be marketed under the name Leqembi,
is a medication that is administered every two weeks. FDA-approved Leqembi for treatment
in patients with early Alzheimer's disease or moderate cognitive impairment.

The drug was authorized through an expedited process, which enables early authorization for
novel drugs that "meet an unmet medical need." Companies must simultaneously carry out
additional clinical studies to verify the advantages of their products or risk having them
pulled off the market.

The organization claimed that the basis for its decision was a mid-stage experiment including
856 Alzheimer's patients.

The working of Leqembi antibody

Leqembi decreased cognitive deterioration in those who took it by 27% after 18 months,
according to a phase 2 clinical trial involving 1,795 patients, which was published in late
September by the drug's developers Eisai and Biogen. On Friday, the FDA stated that it
would analyze the 2 phase results "soon."

The FDA did not consult its advisory group, as it had before it controversially approved
Aduhelm, a different Biogen Alzheimer's medicine, in 2021.
Leqembi is not a treatment for AD; instead, it slows the disease's course by eliminating beta-
amyloid clumps from the brain, which are long known to be one of the disease's primary
causes.

According to specialists, the advantage is minimal, but anything that would allow patients to
spend more time with their families and other loved ones is valuable.

Ivan Cheung, Eisai's U.S. chairman and CEO told NBC News that the bimonthly medication
is anticipated to cost about $25,000 per patient annually. The Centers for Medicare &
Medicaid Services already have coverage restrictions on medications that target amyloid in
the brain. Therefore Cheung predicted that the new drug's initial acceptance could be
constrained.

The medication has been the subject of safety concerns. After the patients had brain swelling
or brain hemorrhage, at least three fatalities may have been related to the medicine.

The medicine caused brain swelling in roughly 12.6% of patients, as opposed to just 1.7% of
patients who took a placebo, according to the company's phase 2 trial results. Approximately
17% of patients taking the medication developed brain hemorrhage, compared to 9% of
patients taking a placebo.

Cheung stated that the business is still "confident" that the drug's advantages outweigh its
drawbacks.

He claimed that the illness was catastrophic and caused significant emotional distress in all
affected families.

Claim of Centres for Diseade Control and Prevention

According to the Centers for Disease Control and Prevention, Alzheimer's disease is the sixth
most common cause of mortality in the United States. The majority of Alzheimer's
medications that the FDA has approved are more focused on treating symptoms than really
decreasing the disease's progression.

The announcement on Friday follows a damning congressional report last week that exposed
the approval of another Alzheimer's medication called Aduhelm. Despite the FDA advisory
committee's conclusion that the medicine created by Biogen was unlikely to work, it was
authorized in 2021. In their report from last week, investigators concluded that the agency
violated its own policies and that its approval of Aduhelm was "rife with anomalies."

In reaction to the news, the advocacy group Public Citizen wrote to the FDA on Wednesday
pleading for them to delay making their judgment on whether or not to approve Leqembi
until the businesses have completed the extra clinical trials required for final approval.

There are supporters of the medicine.

Leqembi should be allowed, according to Donna Wilcock, assistant dean of biomedicine at

the University of Kentucky. She said that the trial's findings were the finest she had "seen for
an Alzheimer's medicine in my 25 years" and that the data supporting Leqembi's application
was "solid."

According to the Alzheimer's Association, the FDA should approve Leqembi for early-stage
Alzheimer's based on the findings of the Eisai and Biogen phase 2 clinical trial.

The group requests that the Centers for Medicare & Medicaid Services rethink its choice of
novel Alzheimer's medicines. The CMS said last year that it would not cover Alzheimer's
medications that target amyloid unless patients are enrolled in a clinical trial due to the weak
data used to support the approval of Aduhelm.
More patients could benefit from having "many months more of recognizing their spouse,
children and grandchildren," according to Maria Carrillo, the Alzheimer's Association's chief
science officer.

Following the FDA's clearance on Friday, the CMS said it might change its mind about
covering some Alzheimer's medicines. According to the agency, "CMS is reviewing the facts
available and may reassess its present coverage."