Mark Gardner’s Post

FDA has approved Eli Lilly’s drug donanemab, which will be marketed as Kisunla. This drug is indicated for the treatment of early symptomatic Alzheimer's disease, which includes people with mild cognitive impairment (MCI) as well as those with the mild dementia stage of Alzheimer’s with confirmed amyloid pathology. Once-monthly Kisunla is the first amyloid plaque-targeting therapy with evidence to support stopping therapy if and when amyloid plaques are removed, setting the stage for potentially lower treatment costs and fewer infusions. Ryan Cross of Endpoints News reports that people living with Alzheimer’s disease and their families will now have the choice of two treatments designed to clear sticky amyloid proteins in the brain and slow the progression of the disease, albeit modestly. The approval of Kisunla kick-starts a competition between Indianapolis-based Lilly, and Eisai and Biogen, which won full approval last year for their treatment Leqembi, which is indicated for the treatment of Alzheimer's in patients with MCI or the mild dementia stage of disease. Linus Health views the growing arsenal of drugs to treat earlier-stage cognitive impairment as a step in the right direction, especially when combined with digital screenings starting at age 55 to detect mild cognitive impairment when lifestyle interventions and potential drug therapy can make the most difference. Read more here: https://bit.ly/3L9U0BR | #Kisunla #AlzheimersDisease #EarlyDetection #Dementia #BrainHealth #FDAApprovals

There can often be a lot of mystery surrounding the FDA approval process, and I am so thankful to my colleague Ryan Chandanais for his help in breaking it down for our clients.   For example, did you know that there are 9 special designations that emerging drugs can apply for, some of which can help speed up the process? He recently wrote a 2-part blog series explaining them all.   Great job, Ryan!

A panel of independent advisors to the FDA has today recommended Eli Lilly’s Alzheimer’s drug donanemab, paving the way for the treatment to receive full approval in the U.S. later this year. If approved, Eli Lilly’s drug would become the second Alzheimer’s drug of its kind to enter the U.S. market after another treatment called Leqembi from Eisai and Biogen. Both questions (provided below) received a unanimous "yes" vote from the 11 advisers. Do the available data show that donanemab is effective for the treatment of Alzheimer’s disease in the population enrolled in the clinical trials with mild cognitive impairment and mild dementia? Yes Do the benefits outweigh the risks of donanemab in the treatment of Alzheimer’s disease in the population enrolled in the clinical trials with mild cognitive impairment and mild dementia? Yes

Did you know there are 9 FDA special designations that could apply to your drug if it’s being developed for an unmet medical need? Having your drug qualify for these special designations could reduce the FDA timeline for reviewal or the time spent in clinical trials prior to FDA submission. In the second part of his blog series, our Drug Pipeline Manager Ryan Chandanais dives into the nine special programs to give you clarity on what each entails. Could your drug qualify? Check out the blog, and reach out to us if you have questions! https://bit.ly/3OIcbkO

Despite a challenging prior year, 2023 saw a remarkable surge in FDA approvals for groundbreaking medicines, marking a turning point in healthcare. From novel oncology treatments to innovative therapies for rare diseases, this bounty of approvals signifies hope and progress for patients globally. Read more about these game-changing approvals below! #HealthcareAdvancements #pharma #InnovativeMedicines

$LLY - Eli Lilly wins US approval for drug to slow Alzheimer’s disease -Lilly's drug, branded as Kisunla™ (donanemab-azbt), is approved by the FDA. -Kisunla to cost $12,522 for 6 months course -Kisunla to cost $695.65 per vial Per Eli Lilly Press Release: -Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants' risk of progressing to the next clinical stage of disease by up to 39%  -Kisunla is the first and only amyloid plaque-targeting therapy that used a limited-duration treatment regimen based on amyloid plaque removal; nearly half of study participants completed their course of treatment with Kisunla in 12 months -Once-monthly infusions of 30 minutes reduced amyloid plaques on average by 84% compared to the start of the study

F.D.A. Delays Action on Closely Watched Alzheimer’s Drug. Eli Lilly’s donanemab was expected to be approved this month, but The Food and Drug Administration has decided to convene a panel of independent experts to evaluate the drug’s safety and efficacy. https://lnkd.in/gub7d24n "The modest benefits would likely not be questioned by patients, clinicians or payers if amyloid antibodies were low risk, inexpensive and simple to administer. However, they are none of these," Dr. Eric Widera, of the University of California, San Francisco, wrote in a JAMA editorial accompanying Lilly's new data. Writing in the New York Review of Books, Natalie de Souza wrote that lecanemab and donanemab by no means halt the disease. They may simply buy people a sliver of time. Furthermore, “Some trials were halted because of bad side effects, others didn’t actually get rid of brain amyloid very well, and in at least one trial the patients on a placebo didn’t decline either, making it impossible to test the drug’s effects. Of the two dozen or so completed phase 3 clinical trials (large trials that enroll many hundreds of patients), by my count we can be confident for only three of them that brain amyloid was strongly reduced” (Feb. 22, 2024 issue). These are the trials behind the donanemab.

Months after the FDA approved Biogen's breakthrough drug, Leqembi, to slow the progression of #Alzheimers Disease, the company continues to face hurdles in patient access and eligibility. https://lnkd.in/eD8A8Kfe With obvious demand and implementation of more convenient and effective drug delivery, Biogen and its Japanese partner, Eisai, hope to significantly increase the number of patients they can help with this promising #treatment. We look forward to seeing future developments as Leqembi continues its journey. If you'd like to learn more about Leqembi, you can read more about some early trials here: https://lnkd.in/eA5g2mGY.

The road to success is rarely straightforward, but today we celebrate a significant milestone in the fight against Alzheimer's. A #donanemab has shown promising effectiveness, bringing hope to millions of patients and their families. This breakthrough is a testament to the relentless dedication of researchers and medical professionals worldwide. Let's continue to support and drive innovation in medical research, for a future where Alzheimer's is a challenge we have conquered. #AlzheimersResearch #MedicalInnovation #HopeForTheFuture

F.D.A. Delays Action on Closely Watched Alzheimer’s Drug. Eli Lilly’s donanemab was expected to be approved this month, but The Food and Drug Administration has decided to convene a panel of independent experts to evaluate the drug’s safety and efficacy. https://lnkd.in/gub7d24n "The modest benefits would likely not be questioned by patients, clinicians or payers if amyloid antibodies were low risk, inexpensive and simple to administer. However, they are none of these," Dr. Eric Widera, of the University of California, San Francisco, wrote in a JAMA editorial accompanying Lilly's new data. Writing in the New York Review of Books, Natalie de Souza wrote that lecanemab and donanemab by no means halt the disease. They may simply buy people a sliver of time. Furthermore, “Some trials were halted because of bad side effects, others didn’t actually get rid of brain amyloid very well, and in at least one trial the patients on a placebo didn’t decline either, making it impossible to test the drug’s effects. Of the two dozen or so completed phase 3 clinical trials (large trials that enroll many hundreds of patients), by my count we can be confident for only three of them that brain amyloid was strongly reduced” (Feb. 22, 2024 issue). These are the trials behind the donanemab.