- 2023 is expected to be a big year for research into Alzheimer’s treatments.
- One drug, called Leqembi, was recently given the green light by the FDA.
- Others are expected to release mid- and late-stage testing data soon.
After a series of failures in recent decades, biotech companies seem to be returning to the difficult and elusive search for treatments for Alzheimer’s.
Alzheimer’s disease affects an estimated 6.5 million Americans and there is no cure. For decades, drugs focused on treating the disease languished in clinical trials, failing to show that they could treat or slow the progression of the disease.
But amid some positive news, companies focused on Alzheimer’s disease said they had received an influx of interest from investors. This month, the Food and Drug Administration granted accelerated approval to a new Alzheimer’s drug called Leqembi, developed by Japanese pharmaceutical company Eisai and Biogen, a biotechnology company based in Cambridge, Massachusetts.
Insider has put together a rundown of the most promising Alzheimer’s treatments today, both those that have gained approval and those that are in the final stages of the research process.
Leqembi just got the green light from the FDA
On Jan. 6, the FDA granted accelerated approval for Leqembi, which means Eisai and Biogen will have to conduct follow-up studies to be covered by Medicare. Eisai said he filed for full FDA approval shortly after receiving his initial green light.
In tests, Leqembi was found to decrease the rate of cognitive decline by 27% in Alzheimer’s patients over 18 months. Cowen analysts estimated in a September note that Leqembi could take about 11% of the Alzheimer’s market three years after its launch, which would generate $4.3 billion in US sales alone.
The drug is focused on the amyloid hypothesis: a theory that a buildup of beta-amyloid in the brain could be responsible for Alzheimer’s disease.
Eli Lilly’s drug donanemab is expected to have data soon, but it just faced a setback from the FDA
The drug behind Leqembi works in a similar way, removing plaque from the brain.
In the first half of this year, Eli Lilly is expected to release data on its Alzheimer’s drug, donanemab, which is being tested in a late stage. On Thursday, the company said the FDA had decided not to grant accelerated approval for the drug, citing the limited number of patients who have received the treatment for at least one year.
Despite the setback, analysts said the news changes little for the company’s outlook, as donanemab would likely have to receive full FDA approval to be widely available to patients. Donanemab is given every four weeks, while Leqembi is given every two weeks.
“I don’t think the accelerated approval period here is important,” said Dr. Daniel Skovronsky, chief scientific and medical officer at Eli Lilly, at the JP Morgan Health Conference earlier this month. “But once we have full data and full approval, our expectation should be a full refund.”
Aduhelm was FDA-approved in 2021 but commercially failed amid controversy
Aduhelm, the first Alzheimer’s drug to be approved in 18 years, was approved by the FDA in 2021 but has faced controversy. It was also developed by Biogen and Eisai.
There is mixed data on whether the drug has worked in patients, and experts have recommended against approval. The Centers for Medicare and Medicaid Services, along with other providers and insurers, have objected to prescribing it to patients, citing a lack of evidence that it worked in clinical trials and safety concerns. As a result, Aduhelm failed commercially.
In late December, a congressional investigation into the drug’s approval found that Biogen had set a high price for the drug despite knowing it would become unaffordable for patients.
Other companies are taking different approaches to Alzheimer’s disease
Some biotechnology companies, such as Lexeo Therapeutics and Shape Therapeutics, have abandoned the beta-amyloid hypothesis and are working to develop gene therapies to treat Alzheimer’s disease.
Others are taking entirely different approaches in hopes that their treatments could offer even better effects for people with Alzheimer’s.
Cognito Therapeutics, for example, is testing a medical headset to treat Alzheimer’s disease; wants to know if light and sound therapy can improve cognitive abilities and reduce neurodegeneration.
In San Francisco, Alector is using immunotherapy to fight Alzheimer’s disease. The company is collaborating with biotech company AbbVie to develop a treatment in an interim trial.
Alector CEO Arnon Rosenthal told Insider this month that while drugs like Leqembi moderately slow the rate of cognitive decline in people with Alzheimer’s, he has received an influx of interest from investors who are hoping immunotherapy treatments could work and possibly enhance the effects of these drugs.
“There’s renewed interest because even though the effect is very modest, they’ve kind of demonstrated that it’s possible to get an approved drug for Alzheimer’s disease,” he said. “So I think both investors and big pharma will be back in the field.”