2023-05-03 17:58:00
Eli Lilly Company
ELI LILLY & COMPANY
+5.41%
closure:0
opening:415.14
High:426.51
low:414.31
cycle:—
Page Quote News Graphs Company Profile Recommendations
More articles on the subject:
said its drug donanemab significantly slowed the progression of Alzheimer’s disease symptoms, although three trial participants died after developing a treatment-related condition.
The efficacy results presented by Lilly were better than investors expected and seem to guarantee that the drug will be approved by the Food and Drug Administration. However, the safety data leave open questions about whether the U.S. government’s Medicare program will pay for the drug, how willing doctors will even be to prescribe it, and whether a similar treatment from Biogen might
BIOGEN IDEC
+0.74%
closure:0
opening:315
High:316.69
low:309.55
cycle:—
Page Quote News Graphs Company Profile Recommendations
More articles on the subject:
And Eisai could be more attractive to patients.
The safety concerns regarding the drug are significant. Doctors are likely to have questions about what Lilly’s efficacy results mean for patients in the real world. Investors focused on Lilly’s disclosure that three patients died during the trial from a condition known as ARIA, a form of brain swelling known to occur after treatment with anti-amyloid antibodies. The ARIA phenomenon raised concerns about all drugs in the anti-amyloid category when last year, Science magazine reported three deaths related to Eisai’s drug.
Still, according to the results, this is a remarkable moment in the fight against Alzheimer’s, a disease that affects more than 6.7 million Americans. After many failures, in recent months there have been two successes, the results of Lilly’s study published today and Eisai’s results from eight months ago, which also showed a slowing of disease progression in patients with early Alzheimer’s. The Eisai trial was the first study to show that there is an advantage to anti-amyloid drugs in the fight against Alzheimer’s and Lilly’s results reinforce this.
Lilly reported that patients treated with its drug donanemab experienced a 35% slowing of cognitive decline compared to people who received a placebo, using an index of Alzheimer’s severity called the Integrated Alzheimer’s Disease Rating Scale. Using another measure called the Clinical Dementia Rating-Sum of Boxes, the slowing of cognitive decline was 36%.
“We are encouraged by the potential clinical benefits that donanemab may provide, although like many treatments for debilitating and fatal diseases, there are associated risks that can be serious and life-threatening,” said Dr. Mark Minton, Lilly’s Group Vice President of Neuroscience Research and Development.
For Biogen and Eisai, Lily’s news isn’t so bad. Not only do their drugs currently appear to be safer than Lilly’s, but Lilly’s experiment does prove that the science behind the drugs is generally correct. That could help Biogen’s crusade to convince the Centers for Medicare and Medicaid, which administers the Medicare program, to pay for Biogen Leqembi’s drug.
In an interview last week, before Lilly released the new data on its drug, Lilly’s chief scientific and medical officer, Dr. Daniel Skobonsky, said that Lilly believes Medicare should fully cover the drugs in the class of Leqembi and donanemab. “I think that it is unethical to require elderly Americans to participate in a registration trial in order to receive a government benefit,” he said. Lilly applied to the FDA for full approval of donanemab based on previous studies, but was denied in January, which it said was due to not enough patients receiving the drug for 12 months Now, Lilly says it will submit the new data to the FDA this quarter.
Comments to the article(0):
Your response has been received and will be published subject to the system policy.
Thanks.
for a new comment
Your response was not sent due to a communication problem, please try again.
Return to comment
#Eli #Lillys #drug #slows #progression #Alzheimers #concerns