By: Melissa Johnson, Partner, Generation Law
Alzheimer’s Disease affects more than 6.5 million Americans with an estimated 2 million people over the age of 65 currently in its early stages. Someone in the United States is diagnosed every 67 seconds. Drug development for the treatment of this form of dementia has been riddled with failures, but Eli Lilly has recently come into the spotlight as showing early success with a promising experimental drug.
Researchers believe the drug, Donanemab, slows decline in Alzheimer’s patients’ ability to think clearly and perform daily tasks by more than a third. Lilly’s clinical trial included more than 1,700 patients and took place over the course of 18 months. 47% of patients taking the drug showed no decline over the course of a year compared with 29% of those taking a placebo. The medication is given via infusion once a month and works by clearing amyloid (the plaque buildup in the brain that is the hallmark of the disease) so effectively that 52% of patients were able to stop taking the medicine in one year and 72% were able to do so by a year and a half. Lilly’s chief scientific and medical officer, Dr. Daniel Skovronsky, describes the results as “the kind of efficacy that’s never been seen before in Alzheimer’s disease.” Based on these results Lilly plans on applying for FDA approval for the drug by the end of this month.
Donanemab’s success comes after another promising medication, Leqembi, received accelerated FDA approval in January of this year. Leqembi delays the progression of the disease in those suffering from mild cognitive impairment or mild dementia. Patients receiving the drug had significant dose and time dependent reduction of amyloid beta plaque which cause the primary symptoms in Alzheimer’s patients.
While both medications come with the inevitable side effects, the overall tone within the community is one of hope, promise and cautious excitement. If and when both drugs receive full FDA approval, patients to whom they are prescribed must still be able to afford their hefty price tags. Widespread coverage by Medicare, which is the primary health insurer for 85% of people with Alzheimer’s, will be critical. Such coverage is expected but not promised once full FDA approval is granted. For Leqembi, such approval will likely be granted in July of this year.