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Eli Lilly and Company, the pharmaceutical company’s headquarters in Alcobendas, Madrid, Spain.
Christina Arias | Cover | Getty Images
Eli Lilly On Monday, it said it had applied for full approval from the U.S. Food and Drug Administration for its Alzheimer’s treatment, donanimab, and expects the agency to do so. Make up your mind by the end of the year.
Eli Lilly is among the pharmaceutical companies racing to market new treatments for mind-stealing disease after Eisai and Biogen Leqembi received FDA approval this month. The signing of the agency was a milestone in Alzheimer’s treatmentalthough medication is not a cure.
The FDA’s approval of Eli Lilly’s Donanemab will expand treatment options for more than 6,000,000 Americans of all ages with Alzheimer’s disease.
On Monday, Eli Lilly also presented final results from an 18-month Phase 3 trial of the monthly antibody infusion drug donanemab at the Alzheimer’s Society International Conference.
Donanemab significantly slowed the progression of Alzheimer’s disease in patients in the early stages of the mind-stealing disease, according to final results. These patients also had a confirmed presence of cerebral plaques associated with the disease.
The Alzheimer’s Association, an organization that advocates for people with the disease, said it “strongly supports” FDA approval of donanimab based on the positive results, which confirms preliminary data released by the company in early May.
The final results address a previous concern of the FDA, which denied Eli Lilly’s request for expedited approval of donanemab in January. At the time, the agency asked the company for more data on patients who had received the treatment for at least 12 months.
In the phase 3 trial, patients treated with dunanimab showed a 35% slower decline in memory, thinking and their ability to perform daily activities at 76 weeks — roughly a year and a half into treatment — compared to those who received a placebo.
Patients in the first stage of the disease had a greater benefit after taking donanimab, showing a 60% slower decrease in cognitive function.
“The results show that starting treatment as early as possible offers the potential for a greater beneficial effect, but there is also potential for slowing disease progression even when treatment is started later in the disease progression,” said Alzheimer’s Association President Maria Carrillo. science officer, in a statement.
Patients taking duanimab were 39% less likely to progress to the next stage of Alzheimer’s disease during the trial.
Almost half of the patients — 47% — who received dunanimab showed no progression of their disease a year after starting treatment, according to the results of the final trial. This compares to 29% for those who did not receive the drug.
More than half of the patients completed treatment in the first year, and 72% completed it at 18 months due to removal of plaque from the brain.
The Alzheimer’s Society said the data point is “noteworthy for patients, families, prescriber and payers because patients may not need to receive this treatment continuously for the rest of their lives.”
But donanmap also comes with some risks.
The treatment can cause brain swelling and bleeding in patients that can, in some cases, be severe and fatal.
Three trial participants died from these side effects, according to Lilly. More than 800 patients received donanimab in the trial.
These side effects have been seen in other Alzheimer’s antibody therapies such as Leqembi.
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