Donanemab's approval around the world: How long will you have to wait?

Last updated: 19 August 2024

Donanemab's approval around the world: How long will you have to wait?

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After the FDA originally hit the brakes on Kisunla (donanemab) by rejecting its accelerated approval application in 2023, the tables have now turned 1. The new Alzheimer's medicine received FDA approval in July 2024 after a group of independent experts recommended its approval in June 2024 2.

For early Alzheimer's patients everywhere, this is a sign of hope. But what approval timelines are you facing if you're in Europe, the UK, or elsewhere? Here's everything you need to know. 

Donanemab: the new Alzheimer's medicine that brings hope

Similar to the previously approved Leqembi (lecanemab) and Aduhelm (aducanumab), also Kisunla (donanemab) works by targeting amyloid plaques in the brain. The accumulation of these plaques is associated with symptoms of Alzheimer's disease. Removing them aims to slow the progression of cognitive decline. 

Donanemab vs lecanemab

There are two main differences between donanemab and its predecessor Leqembi (lecanemab):

  • Frequency of infusions: Lecanemab requires intravenous infusions once every 2 weeks, whereas donanemab is administered once every 4 weeks;
  • Different ways to target amyloid-beta plaques: While lecanemab targets amyloid plaques as they start to form fibers, donanemab binds with them after they have already clumped together 3. 

What is the success rate of donanemab in clinical trials?

In its TRAILBLAZER-ALZ 2 Phase 3 clinical trial, donanemab was used in patients with early symptoms of Alzheimer's disease 4. Some of the key reported results include:

  • there was a 35% slowing of cognitive decline in patients with an intermediate level of tau and clinical symptoms of Alzheimer's. Over 18 months, the slowing of decline was 36%;
  • 47% of patients treated with donanemab experienced no decline on the CDR-SB scale at 1 year after the start of the trial. In the placebo group, 29% of patients experienced no decline;
  • 52% of donanemab patients completed their treatment within 1 year and 72% - within 18 months, as a result of plaque clearance;
  • patients treated with donanemab had 40% less decline in daily tasks performance at the 18-month checkpoint;
  • patients receiving donanemab had a 39% lower risk of progressing to the next stage of the disease 4.

Donanemab's road to FDA approval: What's the status?

With the independent experts' positive recommendation made in June 2024, the road to donanemab's FDA approval was cleared. On 2 July, 2024, Kisunla (donanemab) officially received FDA approval 11. 

When will donanemab get EMA approval?

Donanemab's marketing authorization application in the EU has been in review since August 2023. Typically, the EMA approval process takes up to 210 days, but in this case, it's taking longer. It's theoretically possible for donanemab to be approved in Europe within 2024. However, considering the approval delay its predecessor Leqembi is still experiencing, it's impossible to make a timeline prediction. 

When will donanemab be available in Europe?

If we assume the best-case scenario, in which donanemab gets its European approval before the end of 2024, that still doesn't mean that it will become available across Europe at the same time. 

Each EU member state has its own local process and timeline for launching newly approved medicines. The EU average is 511 days, with Germany being the fastest (133 days) and Romania - the slowest (899 days) 5. 

In other words, even looking at the best-case scenario, the earliest some countries in Europe may make donanemab available is mid-2025. Patients in other countries may be facing over 2 years of additional waiting time.

Is MHRA approval in the cards for donanemab?

While an MHRA approval application has not been submitted for donanemab, that's not necessary for the MHRA to approve the medicine. Based on the International Reliance Procedure in place after Brexit, medicine approvals by another trusted regulatory body (e.g. FDA, EMA) can be directly adopted by the MHRA. Whether this will be the case with donanemab, of course, is difficult to say.

When will donanemab be available in the UK?

Let's assume the best-case scenario, in which the MHRA adopts an EMA or FDA approval of donanemab. That would mean that around mid-2025, donanemab could theoretically be available in the UK.

However, for it to be included on the NHS, a positive evaluation from NICE is needed. NICE has already initiated a review of the medicine, with an expected decision date in September 2024. This is positive news, as it means that donanemab could quickly become available on the NHS if and when it is approved in the UK. 

When will donanemab be available in other countries?

Donanemab is being evaluated for approval in several other countries, including:

  • Australia: The TGA has been reviewing donanemab's application since October 2023 6. The Australian approval process takes up to 330 days, meaning that donanemab could theoretically be approved around September 2024.
  • Canada: Donanemab is also being considered for approval in Canada (under review since February 2024) 7. Approval decisions by Health Canada can take between 7 months and 1 year, meaning that donanemab could theoretically get approval in Canada towards early 2025. 
  • China: In November 2023, Eli Lilly submitted its approval application for donanemab to the CDE In China. The approval timelines in China have improved since its 2015 regulatory reform, and are now at an average of 6.8 months 8. This means that the CDE may theoretically approve donanemab in mid-2024, potentially making it the first country to greenlight the new Alzheimer's medicine. Whether that happens, only time will tell. 
  • Japan: Eli Lilly filed its approval application for donanemab to Japan's PMDA already back in September 2023 9. Japan's medicine approval process has traditionally been quite long, and it can take up to a year. With this in mind, it's possible that Japan joins China (and, possibly the USA) to give the first global approvals to donanemab in late 2024. Whether this timeline will materialize, remains to be seen. 

What if the medicine approval process of your country takes a long time, or you're based somewhere where it hasn't even started? 

How to get donanemab before it's approved in your country

Are you an early Alzheimer's patient? If your doctor is of the opinion that you might benefit from treatment with donanemab, you may not need to wait for its local approval. Instead, your doctor and you could consider joining a clinical trial. Or, buying and accessing donanemab via Named Patient Import.

Join a donanemab clinical trial

One way to access donanemab is to enroll in a clinical trial. This can often be easier said than done, as you and your doctor would need to find a trial that is currently recruiting participants in your country. You would also have to meet their eligibility criteria and accept the risk that you may be assigned to the control group in the trial. 

Here are some good places to start looking for ongoing donanemab clinical trials:

  • ClinicalTrials.gov: This is a database with all clinical trials in the USA. Some of the trials are also open to international participants. An example is the TRAILBLAZER-ALZ 5 clinical trial with donanemab, which is open to patients in the UK, China, South America, and other countries 10.
  • EUClinicaltrials.eu: This is a database with all clinical trials in the European Union. Currently, it contains limited information on trials launched before 31 January 2022. For those trials, you can refer to the EU Clinical Trials Register.
  • myTomorrows: This organization supports patients in finding treatment options in clinical trials.

Buy donanemab via Named Patient Import

In most countries, patients are legally allowed to buy and import medicines that could enhance their quality of life or address life-threatening conditions. If you want to access donanemab before its approval in your country, this might be an option for you and your doctor.

The regulation making this possible is known as the Named Patient Import. There may be variations across countries in terms of the specific administrative requirements. However, in all cases these criteria must be met:

  • The medicine in question has market approval in another country and is not (yet) approved or available in the patient's country;
  • There is no alternative on the local market;
  • The medicine is for personal use;
  • The patient has a prescription from their treating doctor;
  • The doctor takes responsibility for the treatment. This might require different documentation from country to country.

Do you want to use the Individual Named Patient Import regulation to get donanemab before its EU approval (or its approval in the UK, China, Canada, Japan, Australia, or elsewhere)? You will first need to consult your treating doctor and get a suitable prescription.

Already have a prescription? Our team can support you with buying donanemab, wherever you are. Get in touch with us for more information.

 

References:

  1. Beasley, D. Eli Lilly says U.S. FDA rejects accelerated approval for Alzheimer's drug. Reuters, 19 January 2023.
  2. Donanemab: FDA experts recommend approval of Alzheimer’s drug. The BMJ, 14 Jun 2024.
  3. Leqembi (Lecanemab) vs Donanemab For Alzheimer's: What's The Difference?. Local Infusion, Accessed 18 June 2024.
  4. Lilly's Donanemab Significantly Slowed Cognitive and Functional Decline in Phase 3 Study of Early Alzheimer's Disease. Investors.lilly.com, Accessed 18 June 2024.
  5. EFPIA Patients W.A.I.T. Indicator 2021 Survey. EFPIA, Accessed 18 June 2024.
  6. Kisunla Eli Lilly Australia Pty Ltd. Therapeutic Goods Administration (TGA), Accessed 18 June 2024.
  7. Drug and health product submissions under review (SUR). Canada.ca, Accessed 18 June 2024.
  8. Davidson, A., et al. China Regulatory Reform: An Update on Review Timelines and Drug Lag. PPD, Accessed 18 June 2024.
  9. Lilly's Alzheimer's Therapy Filed in Japan, Approval Eyed in 2024. PHARMA JAPAN, 27 September 2023.
  10. A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5). ClinicalTrials.gov, Accessed 18 June 2024.
  11. FDA Approves Kisunla. Drugs.com, Accessed 03 July 2024.