Newly-approved Alzheimer’s drug is a major breakthrough

Sufferers, their families and their caretakers are happy about the news from the FDA in the latest fight against Alzheimers, a devastating disease that robs individuals of their personality, autonomy, and ultimately life. The FDA recently granted full approval to a drug proven to slow the progression of the devastating condition, which is a major step for sufferers of this disease.

The drug, called Leqembi, is administered through IV infusion once every two weeks. A large trial funded by the drug’s makers found Leqembi slowed the progression of the disease by about 27%. Leqembi targets a specific protein that forms plaques in the brains of Alzheimer’s patients. While the drug cannot stop Alzheimer’s from getting worse, data suggests that Leqembi may be able to slow cognitive decline by five months over a period of 18 months for people with mild symptoms.

The Food and Drug Administration on Thursday gave full approval to the Alzheimer’s drug Leqembi, and Medicare said it would cover much of its high cost. Leqembi has been available under accelerated FDA approval since January, but at a cost of more than $26,000 a year before insurance, many patients couldn’t access or afford it. Although Medicare will cover 80 percent of Leqembi’s $26,500 cost, patients could still be on the hook for thousands of dollars in co-payments.

Infusion centers are gearing up for an anticipated surge in new patients. Sue Rottura of Vivo Infusion said, “In certain areas, I anticipate we will receive probably at least 15 to 20% more patient referrals for this drug.” 

Data from a large clinical trial suggests that the drug — administered every two weeks as an intravenous infusion — may slow decline for people with mild symptoms of dementia or a pre-Alzheimer’s condition called mild cognitive impairment. The F.D.A. directs doctors not to treat patients without testing to confirm they have an accumulation of the protein amyloid, a hallmark of Alzheimer’s that Leqembi attacks. 

Leqembi cannot repair cognitive damage, reverse the course of the disease or stop it from getting worse. Reports say about five million people have progressed too far to be eligible for Leqembi but about 1.5 million people in the United States are estimated to be in the beginning phases of Alzheimer’s.