Eli Lilly announced Monday that it has applied for full approval from the U.S. Food and Drug Administration for its Alzheimer’s drug donanemab and expects the agency to make a decision by the end of the year.
The filing is based on positive results from phase III clinical trials of donanemab, which significantly slowed the progression of Alzheimer’s disease in patients with the early stages of the debilitating disease.
The results also showed that treating patients with early stages of the disease can slow the progression of Alzheimer’s disease by around 40 to 60%.
“The sooner you start using the drug, the slower it can be,” Eli Lilly CEO David Ricks said Monday in an interview on CNBC’s Squawk on the Street.
Eli Lilly joins Eisai and among pharmaceutical companies struggling to commercialize new treatments for the disease biogens The drug Leqembi received FDA approval this month. The agency’s approval of Leqembi was a milestone in the treatment of Alzheimer’s, although the drug and donanemab are not cures.
Both treatments are monoclonal antibodies that target amyloid plaques in the brain, which are thought to be hallmarks of the disease.
FDA approval of Eli Lilly’s donanemab would expand treatment options for the more than 6 million Americans of all ages who have Alzheimer’s disease, the fifth leading cause of death in adults over the age of 65.
The company did not disclose how it would price donanemab after potential approval.
But the Centers for Medicare & Medicaid Services has said Medicare will cover Alzheimer’s drugs — as long as they get full FDA approval and healthcare providers participate in a registry system that collects data on how the drugs work in the real world.
Ricks said the registration requirement appears to be a “pretty easy gesture” that “doesn’t require much effort.” However, he pointed out that the data collected in the process appears to be “of fairly little value”.
“So we hope we have that [requirement] lifted in a timely manner and achieved full post-approval coverage for donanemab,” Ricks told CNBC.
Positive study results on Alzheimer’s treatment by Lilly
Eli Lilly also presented the final results of the 18-month phase III study of the monthly antibody infusion donanemab at the Alzheimer’s Association international conference in Amsterdam on Monday. The results confirm the first data that the company published in early May.
The final results also address an earlier concern from the FDA, which in January denied Eli Lilly’s application for donanemab’s accelerated approval. At the time, the agency asked the company for more data on patients who received the treatment for at least 12 months.
Eli Lilly and Company, headquarters of a pharmaceutical company in Alcobendas, Madrid, Spain.
Cristina Arias | cover | Getty Images
The study followed more than 1,700 patients with early-stage Alzheimer’s disease who had been identified as having amyloid plaque. About half of the participants received donanemab.
After 76 weeks – about a year and a half of treatment – patients who received donanemab showed a 35% slower decline in memory, thinking and the ability to perform daily activities compared to patients who received a placebo.
Patients in the earliest stages of the disease had greater benefit after taking donanemab and showed a 60% slower decline in cognitive function.
The study also found that patients taking donanemab were almost 39% less likely to progress to the next stage of Alzheimer’s disease.
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According to the final study results, almost half of the patients – 47% – who received donanemab showed no progression of the disease one year after the start of treatment. This compares to 29% for those who did not receive the drug.
The Alzheimer’s Association, an organization that advocates for people with the disease, said it “strongly” supports FDA approval of donanemab based on the positive results.
“The results demonstrate that starting treatment as early as possible offers the possibility of a greater beneficial effect, but also that there is potential for slowing disease progression even when treatment is started later in the disease course,” said Maria Carrillo, Chief Science Officer of the Alzheimer’s Association, in a statement.
Benefits and side effects of donanemab
More than half of the patients completed treatment within the first year, and 72% completed it within 18 months due to amyloid plaque clearance.
The Alzheimer’s Association said this data point is “important for patients, families, prescribers and payers, as patients may not need to receive this treatment continuously for the rest of their lives.”
Donanemab cleared amyloid plaque after six months in 34% of patients who had moderate levels of a protein called tau, which can become toxic and kill neurons.
At 76 weeks, donanemab cleared plaque in approximately 80% of patients with the same tau levels. This compares to 0% plaque clearance in those taking the placebo over the same period.
However, the benefits of donanemab must be weighed against the risks.
Drugs that target and clear amyloid plaques can cause patients to experience brain swelling and bleeding, which in some cases can be serious and even fatal.
According to the study results, almost 37% of people taking donanemab had these side effects, called amyloid-related imaging disorders, compared to almost 15% who received a placebo. According to Lilly, three study participants died from these side effects.
These side effects have also been seen with Leqembi.