United States – FDA on Tuesday okayed Eli Lilly’s Alzheimer’s drug as announced by the company, opening doors for another contender in the market of a new class of drugs that merely slows the progression of the disease moderately.
The agency in mid of the month convened an advisory committee to review the safety and efficacy of the drug, which has been dubbed donanemab, after the agency postponed approval in March, as reported by The Hills.
Advisory Committee Review
The decision to make a panel meeting was a shocker to the company that, in the past year, submitted its normal approval application of donanemab and expected to be approved by early 2024.
Experts who advised the FDA endorsed a recommendation of approval for the drug.
Donanemab, currently marketed as Kisunla, is a monoclonal antibody that specifically binds to amyloid, a plaque in the brain. It is designed for initial disease and is given once a month through drip infusion.
As for the second question, Lilly said the drug will be available in the coming weeks.
Clinical Trial Results
Lilly stated that donanemab reduced the progression of Alzheimer’s disease by 35% as compared to placebo treatment in the early-stage disease involving 1,700 patients in an 18-month trial. From a practical point of view, that means that progression was delayed by approximately three to four months.
Some of the adverse effects described in the trial are severe, given that the benefit may not in any way outweigh the risk. Three people died after suffering from severe conditions and had brain bleeding or swelling.
The amyloid-related drugs can very substantially lower the levels of amyloid beta, a sticky substance in the brain, but there is some doubt about the extent of the impact of this change.
Impact on Alzheimer’s Treatment
Currently, over 6 million Americans receive an Alzheimer’s diagnosis, and this statistic will only increase as the population increases in age. It is not curable, and there are about 1 million such patients with early-stage disease who may be most responsive to the drug.
Donanemab is the third amyloid-targeting Alzheimer’s drug to gain FDA approval since 2021. Both Aduhelm and Leqembi were developed in collaboration with Eisai, however Aduhelm was marred by controversy from the very beginning and was withdrawn in January.
In contrast to Leqembi, donanemab treatment can be ceased after the amyloid plaque burden is significantly reduced, minimizing its costs and the number of required infusions, according to Lilly, as reported by The Hills.
Cost and Insurance Coverage
Each vial of Kisunla costs USD 695. 65, Lilly said, which is equivalent to USD 32,000 per year.
The actual cost will thus depend on how long patients will take the drug, though the company observed that Medicare Part B will cover and offer some payment—patients will be expected to pay a 20 percent coinsurance after the deductible.