US FDA approves Eli Lilly’s Alzheimer’s drug donanemab; Alzheimer's Association hails the approval
Overview
The US Food and Drug Administration on Tuesday approved donanemab for treatment of Alzheimer’s disease, after clinical studies indicated Eli Lilly’s drug could significantly slow cognitive decline, following years of delays to get the experimental treatment to the market.
Donanemab for Alzheimer’s Disease
Donanemab is the second drug approved by the US FDA for treating Alzheimer’s disease, after Biogen and Eisai’s treatment lecanemab—sold under the brand name Leqembi—was approved last year.
Kisunla: Regulatory Approval
Eli Lilly’s donanemab—to be sold under the brand name Kisunla—received regulatory approval as a monthly injection after an 18 months clinical trial showed very meaningful results in slowing cognitive and functional decline in patients with Alzheimer’s, according to the company statement.
Trial for Approval
- In the clinical trial, totaling more than 1,700 participants, Eli Lilly separated patients if they had an early or advanced form of the disease.
- Among the two groups, participants treated with donanemab compared with a placebo had a 39% lower risk of their disease worsening.
Celebration from Alzheimer's Association
The Alzheimer's Association celebrates the US Food and Drug Administration action to approve donanemab of Eli Lilly for the treatment of people living with early symptomatic Alzheimer's disease, which includes mild cognitive impairment and the mild dementia stage of Alzheimer's disease, with confirmed amyloid plaques.
Statement from Alzheimer's Association
- his is real progress. Today's approval allows people more options and greater opportunity to have more time,"" said Joanne Pike, DrPH, Alzheimer's Association president and CEO.
- Having multiple treatment options is the kind of advancement we've all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease.
Early Detection and Diagnosis
- Because multiple US FDA-approved Alzheimer's treatments are now available, early detection and diagnosis are even more critical to ensure individuals receive the most benefit.
- Access to these treatments should not be delayed at any stage or by any entity — not the Centers for Medicare & Medicaid Services (CMS) coverage with evidence development policy, private insurers, health systems or doctors.
- Too many roadblocks have prevented individuals from getting equitable access to these beneficial treatments for far too long,"" said Pike. ""It is equally important that clinicians and health care systems are informed and prepared to help the individuals who could benefit. The Alzheimer's Association is working with health systems and providers to ensure they have the tools and resources to meet the needs of their patients.
ALZ-NET
- The Association strongly encourages prescribers to participate in the Alzheimer's Network for Treatment and Diagnostics (ALZ-NET), which is gathering real world data on how people from all backgrounds and communities respond to novel US FDA-approved Alzheimer's therapies.
- ALZ-NET provides ongoing education and resources for clinicians, patients, and families, helping them stay informed about the latest developments in Alzheimer's research and care.
Statement from CSO: Alzheimer's Association
These recent approvals generate hope for continued advances. For researchers, our next horizon is to develop new treatments that address different components of the disease, and that work together to have an even bigger effect on slowing or stopping disease progression for all communities,"" said Maria C. Carrillo, chief science officer and medical affairs lead, Alzheimer's Association.
3rd Approval
- This is the third approval of an Alzheimer's treatment that changes the underlying course of the disease.
- Results from studies of a wide variety of Alzheimer's and dementia therapies will be reported at the Alzheimer's Association International Conference (AAIC), July 28 to August 1 in Philadelphia.
Statement from the Participant
- Today's decision by the US FDA is good news for those of us living with early Alzheimer's,"" said Barbara Eades, of Chattanooga, Tennessee, who was diagnosed with mild cognitive impairment (MCI) in 2018.
- I was fortunate to participate in the clinical trial and receive this treatment. It has provided me an opportunity to live my life fully, for more time. I'm able to keep doing what I'm passionate about: sing, remain active in my church and spend time with my friends and family.
Disppointment
- The Alzheimer's Association is disappointed that so little progress is being made to improve representation of all affected populations in Alzheimer's clinical trials. For example, Alzheimer's and other dementia disproportionately affect Black/African Americans and Hispanic/Latino Americans yet, too often, these groups are severely underrepresented in treatment studies.
- It is critical that clinical trial study populations reflect the communities these treatments intend to serve.
