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title: Eli Lilly&#x27;s Alzheimer&#x27;s Drug Shows Greatest Benefit Yet
description: Donanemab slowed cognitive decline in people with early Alzheimer’s disease by 35%, according to the company.
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article:published_time: 2023-05-03T16:17:51.000Z
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og:description: Donanemab slowed cognitive decline in people with early Alzheimer’s disease by 35%, according to the company
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![](https://static.time.com/v3/assets/bltea6093859af6183b/blt69ca4c96441cc44f/698a3c8947ca388e4e3babdb/dona-PET-images.jpg?branch=production&width=805&quality=75&auto=webp&crop=16:9)


# Eli Lilly's Alzheimer's Drug Shows Greatest Benefit Yet

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## Video: The Race to Make a Vaccine for Breast Cancer

[Watch (HLS stream): The Race to Make a Vaccine for Breast Cancer](https://cdn.jwplayer.com/manifests/W5jcvwLu.m3u8) (8:09)

![The Race to Make a Vaccine for Breast Cancer](https://cdn.jwplayer.com/v2/media/W5jcvwLu/poster.jpg?width=720)

_Published 2022-10-05. Scientists believe there is a future in which women can be vaccinated against breast cancer._


![Alice Park](https://static.time.com/v3/assets/bltea6093859af6183b/blt9b1ff6b12c3a4c3f/698a0b4397cdff3e366ba723/200116_Time_Headshots_Day552832-e1583529256299.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1:1)

by 

[Alice Park](https://time.com/author/alice-park/)


![Alice Park](https://static.time.com/v3/assets/bltea6093859af6183b/blt9b1ff6b12c3a4c3f/698a0b4397cdff3e366ba723/200116_Time_Headshots_Day552832-e1583529256299.jpg?branch=production&width=96&quality=75&auto=webp)

## Alice Park


Senior Correspondent

May 3, 2023 4:17 PM UTC

![Brain scans show clearance of amyloid plaques, shown in red, in two patients, A and B, who received donanemab, compared to higher levels of amyloid in a patient who received placebo \(bottom\) in Eli Lilly's trial. ](https://static.time.com/v3/assets/bltea6093859af6183b/blt69ca4c96441cc44f/698a3c8947ca388e4e3babdb/dona-PET-images.jpg?branch=production&width=1200&quality=75&auto=webp&crop=3:2)

Brain scans show clearance of amyloid plaques, shown in red, in two patients, A and B, who received donanemab, compared to higher levels of amyloid in a patient who received placebo (bottom) in Eli Lilly's trial.

Brain scans show clearance of amyloid plaques, shown in red, in two patients, A and B, who received donanemab, compared to higher levels of amyloid in a patient who received placebo (bottom) in Eli Lilly's trial. Eli Lilly

![Alice Park](https://static.time.com/v3/assets/bltea6093859af6183b/blt9b1ff6b12c3a4c3f/698a0b4397cdff3e366ba723/200116_Time_Headshots_Day552832-e1583529256299.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1:1)

by 

[Alice Park](https://time.com/author/alice-park/)


![Alice Park](https://static.time.com/v3/assets/bltea6093859af6183b/blt9b1ff6b12c3a4c3f/698a0b4397cdff3e366ba723/200116_Time_Headshots_Day552832-e1583529256299.jpg?branch=production&width=96&quality=75&auto=webp)

## Alice Park


Senior Correspondent

May 3, 2023 4:17 PM UTC

In a May 3 [press release](https://investor.lilly.com/news-releases/news-release-details/lillys-donanemab-significantly-slowed-cognitive-and-functional), Eli Lilly announced encouraging results from its latest study of its Alzheimer’s drug candidate, donanemab.

In the Phase 3 study, which included more than 1,000 people with early signs of Alzheimer’s disease, people receiving donanemab experienced 35% slower cognitive decline, as measured on cognitive tests, than people receiving placebo. In addition, those getting the drug showed 40% less decline in the ability to perform daily activities such as driving, managing their finances, and holding conversations. That’s an important metric for patients and their caregivers, as it can help more people live as independently as possible for as long as possible as the disease progresses.

The results are the most encouraging yet for any drug that targets amyloid, the protein that builds up in the brains of Alzheimer’s patients and leads to a gradual culling of nerves involved in memory and other cognitive skills. “This further underscores the inflection point we are at for the Alzheimer’s field,” said Maria Carrillo, chief science officer for the Alzheimer’s Association, in a statement. “The progress we’ve seen in this class of treatments, as well as the diversification of potential new therapies over the past few years, provides hope to those impacted by this devastating disease.”

---

### More from TIME


---

**Read More:** [_A New Alzheimer’s Drug Gave Patients Hope. Millions Can’t Get It_](http://A New Alzheimer's Drug Gave Patients Hope. Millions Can't Get It)

The only drugs currently approved to treat Alzheimer’s—[aducanumab](https://time.com/6081333/biogen-alzheimers-drug-aduhelm-fda-controversy/) and [lecanemab](https://time.com/6244798/fda-approves-lecanemab-alzheimers-drug/)—slow cognitive decline to a lesser extent, and early promising studies on donanemab had Alzheimer’s experts hopeful that Eli Lilly’s drug would benefit patients to a greater extent. The company plans to request approval from the U.S. Food and Drug Administration (FDA) for donanemab for early Alzheimer’s patients this quarter, and will file additional applications for broader global approval.

But even if does gain FDA approval, access to the medication could be an issue. Aducanumab, the first drug approved to treat Alzheimer’s, isn’t widely available, since the Centers for Medicare and Medicaid Services (CMS) decided it would only reimburse patients who use the drug if they are enrolled in a clinical study to continue researching the effectiveness of the medication. Coverage for lecanemab, the second [recently approved](https://time.com/6244798/fda-approves-lecanemab-alzheimers-drug/) drug, is [also restricted](https://time.com/6245670/lecanemab-medicare-costs-alzheimers-drug/) by CMS, since it also works by targeting amyloid.(The Veterans Affairs Administration, however, [does cover](https://www.va.gov/formularyadvisor/DOC%5FPDF/CFU%5FLecanemab-irmb%5FLEQEMBI%5FCFU.pdf) lecanemab for its beneficiaries.)


CMS says it restricts coverage of anti-amyloid medications because these medications require further study before Medicare and Medicaid can reimburse all users. Under that policy, coverage of donanemab, despite its strong positive effect, could also be limited. “The Centers for Medicare & Medicaid Services (CMS) policy to block Medicare access to Food and Drug Administration (FDA)-approved Alzheimer’s treatments is in stark contrast to scientific evidence, is unprecedented and must be reversed immediately,” said Joanne Pike, president and CEO of the Alzheimer’s Association, in a statement.


## Transcript

Vaccines are often called The Miracle of modern medicine for their ability to Target the immune system against disease-causing, viruses and bacteria. Since they work against infectious diseases, why not against other conditions that have long plagued Humanity like cancer. To say we're working to develop a vaccine to prevent Cancers and individuals for the rest of your life. It sounds like Star Wars but it's not a concept that's totally unchartered me vaccines against human papillomavirus which is causative agent in certain types of human cancers. Work to prevent cancer in those individuals who get vaccinated and so are we?

We no longer is nikoli more about the immune system in the last 20 years in the face of cancer. Studies and cancer. And now it's covid that we can bring this knowledge to this big goal of using a new system to prevent all types of cancers and and do so with humility and optimize the immune response against cancer by training cells to recognize tumors as foreign. Once that happens in breast cancer, it may be possible to not only prevent Prince's in people who have already had cancer, but to even prevent it in the first place, I was diagnosed in 1987 and I wasn't treated much differently from what the treatments or today.

Oh, wow. Yes, there's a lot of focus on immunotherapy and that's exciting. It's exciting from a research perspective but it hasn't really made a difference in women's lives. Yet, we believe that a vaccine approach is certainly the key and primary prevention or preventing people from getting breast cancer to begin with because we believe that that is the future, that that is one of the areas that we should be focusing on now. We believe not only will it save lives, but it will also be less toxic than existing Therapies. You know, technologies that have have been developed over the past five to ten years.

Are number one, immune checkpoint Inhibitors. So, immune checkpoint Inhibitors is a form of therapy that has been you know now approved by the Food and Drug Administration for use in targeting a number of different cancers were, we had has been effective lasso in in certain tumors. And so, the reason that vaccines don't work against metastatic deposits of tumor is because the tumors themselves. Throw up a number of Walls that ultimately prevents the immune response from acting and killing the tumor. So the whole idea just like an infectious disease, vaccine used to identify what's foreign in the tumor as much as possible and to really craft A vaccine that targets what's foreign because that's really word.

You know we're going to see the power of the immune response and in shrinking or preventing a cancer is having multiple targets within the tumor. But also having them be very foreign at the Mayo. Clinic Newton has developed a vaccine targeting, a very early form of breast cancer called ductal carcinoma inside you or DC, is he is working with his colleague dr. Amy degnan to test that vaccine experts, have debated in recent years, whether dcis is actually cancer since it involves lesions that remain in the ducts of the breast tissue and don't spread throughout the breast as other forms of breast cancer.

Do about 50 1,000 women. A year are diagnosed with DC is in the US and some of those cases will become cancerous. Although doctors, can't predict which one As a result many women with the condition up to have radiation and surgery to remove the lesions to avoid the risk of developing cancer. if the immune system could be trained to attack tcis instead that would potentially help women to avoid the more invasive treatments, which some experts believe might be over treating their condition We are interested in pushing forward, you know, toward a goal of vaccines for breast cancer prevention. And so one strategy to do that is to then evaluate a vaccine that we found was safe and women who had invasive cancer and apply it to women who don't have invasive cancer yet who have this dcis and evaluate what kind of immune response we see in those women.

And one of the things that were specifically interested in this study to see is what kind of response do we see in the breast tissue after this vaccine is given, can we find evidence that the immune system is reacting to the vaccine and potentially, you know, trying to clear out these cancer cells in the breast tissue. So, in this trial, we give the vaccine for several doses of the vaccine before surgery, and women who have dcis. And then at the time of We're removing their dcis as we would not normally to treat it, but we're also able to then investigate the breast tissue and the area of DCs and and see what is happening with the immune response there after the vaccine, the team at the Abramson Cancer Center, at Penn Medicine, is studying a different approach to a breast cancer vaccine.

They are currently a rolling about 16th bull who have been diagnosed with cancer and who have the genetic mutations, bcra one or bcra to which put them at higher risk of developing breast cancer to see if vaccinating them will lower their chance of recurrence. The researchers also had to study a couple dozen people with the genetic risk, but who has not yet been diagnosed with cancer to see if the vaccine could lower their risk of ever developing the disease. It's a, it's a game changer and we recognize that we have a ways to go. But right now, if you're a 25 year old woman who has undergone genetic testing and is told that you have a safe for me to yishun, you're talkin about raining for the rest of your life for your breasts or deciding to do a bilateral, mastectomy have your breasts removed and at this point we had no effective screening for ovarian cancer.

And so we strongly recommend that individuals have their ovaries removed between ages, 35 and 44 a beer, signaling carrier, putting them into early menopause. And with all the attendant Dallas ring consequence that we really have not had great options apart from surgical options. And, you know, we're working on many different types of strategies to try alternative National the natural history. But this concept of immune interception being able to use the immune system to change the natural history for these individual is so critical. We are probably at the end of the era of using cancer, vaccines with great hope in a patient, whose party been treated with everything in the tumor is still Advanced to using these vaccines and all our new knowledge in patients, who are at risk for relapse or individuals who are simply a high risk for cancer and we want to prevent so prevention.

And survivorship is what cancers going to be about him. 10 years, I think vaccines will play a part in ensuring

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