Eli Lilly and Company, a pharmaceutical company based in Madrid, Spain, announced on Monday that it has submitted an application for full approval of its Alzheimer’s treatment, donanemab, to the U.S. Food and Drug Administration (FDA). The company anticipates a decision from the FDA by the end of the year. This application is supported by positive results from a phase-three clinical trial, which demonstrated that donanemab significantly slowed the progression of Alzheimer’s in patients at the early stages of the disease. The trial also revealed that treating patients in the earliest stages of Alzheimer’s can slow progression by 40% to 60%.
In an interview with CNBC, Eli Lilly CEO David Ricks emphasized the importance of beginning treatment early and suggested that earlier use of the drug may yield greater benefits in slowing the disease progression.
Eli Lilly’s submission for approval comes in the wake of FDA approval of the drug Leqembi, developed by Eisai and Biogen. Both Leqembi and donanemab are monoclonal antibodies that target amyloid plaque in the brain, a characteristic feature of Alzheimer’s disease.
If donanemab receives FDA approval, it would provide additional treatment options for the more than 6 million Americans of all ages who suffer from Alzheimer’s. Alzheimer’s is the fifth-leading cause of death for adults aged 65 and older.
The pricing for donanemab has not been disclosed by Eli Lilly. However, Medicare has announced that it will cover Alzheimer’s drugs with full FDA approval, provided healthcare providers participate in a registry system to collect real-world data on drug efficacy. David Ricks expressed the hope that this requirement will be rescinded in the future to ensure full coverage for donanemab.
In addition to the FDA application, Eli Lilly presented final results from its 18-month phase-three trial of donanemab at the Alzheimer’s Association International Conference in Amsterdam. These results confirmed the initial data released by the company in May and addressed concerns raised by the FDA, which initially rejected the expedited approval of donanemab in January.
The trial involved more than 1,700 patients in the early stages of Alzheimer’s and demonstrated that donanemab led to a 35% slower decline in memory, thinking, and daily activities compared to a placebo. Patients in the earliest stage of the disease experienced a 60% slower decline in cognitive function. Furthermore, patients who received donanemab were almost 39% less likely to progress to the next stage of Alzheimer’s.
Almost half of the patients who received donanemab showed no disease progression a year after starting treatment, emphasizing the potential benefits of early intervention. The Alzheimer’s Association expressed strong support for FDA approval based on these positive results.
While donanemab’s benefits are significant, they must be weighed against the risks. Drugs that target and clear amyloid plaque may cause brain swelling and bleeding, which can be severe and even fatal. The trial results revealed that nearly 37% of patients on donanemab experienced these side effects, known as amyloid-related imaging abnormalities, compared to 15% of those who received a placebo. Three trial participants died from these side effects. Similar side effects have also been observed in Leqembi.
In conclusion, Eli Lilly’s application for FDA approval of donanemab represents a significant milestone in the search for effective treatments for Alzheimer’s disease. The positive trial results and potential benefits of donanemab offer hope for patients and their families, although the risks associated with the drug must be carefully considered.
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