Eli Lilly said it expects the Food and Drug Administration (FDA) to act by the end of the year on its application for approval of its monoclonal antibody called donanemab.
Donanemab slowed Alzheimer’s disease progression by 35 percent relative to placebo in an 18-month clinical trial that enrolled 1,700 patients with early-stage disease.
In practical terms, that translated to delaying progression by about four months. It also means the drug performs at least as well as the newly approved Leqembi (lecanemab), which was found to reduce progression by about 27 percent.
Both donanemab and Leqembi are part of a new class of Alzheimer’s drugs called anti-amyloid treatments, because they target amyloid plaque in patients’ brains. They offer promise, but serious questions remain.
Both significantly reduce the levels of plaque, but there’s debate about how much that will actually help.
Supporters argue that for the patients who benefit, the drugs can stave off memory loss long enough to buy them a few extra months with family and loved ones.
The main safety concern is brain swelling or bleeding, which is often mild but sometimes can be serious or even fatal. During Lilly’s trial, three deaths were attributed to the drug.
Patients using the treatments need repeated brain scans to monitor for those side effects, which can be costly if they’re not covered by Medicare or private insurance.
The Centers for Medicare and Medicaid Services on Monday proposed to expand its coverage of PET scans that are used to help diagnose Alzheimer’s disease, which would likely ease at least some of the cost concerns. Currently, Medicare will only cover one PET scan per lifetime of a patient, and then only if they are participating in clinical trials.
