In a significant development in the fight against Alzheimer's disease, the Food and Drug Administration (FDA) has granted approval for a new drug called Kisunla from pharmaceutical company Eli Lilly. The drug has demonstrated in clinical trials its ability to modestly slow the decline in memory and thinking abilities among individuals suffering from the disease.

Kisunla, previously known as donanemab, is a monoclonal antibody infusion that will be administered every four weeks. This approval adds another treatment option to the limited arsenal available for managing Alzheimer's, a devastating condition affecting millions of Americans. Last year, a similar drug called Leqembi received full FDA approval, providing hope for patients and healthcare professionals alike.

According to the Alzheimer's Association, an estimated 6.7 million Americans aged 65 and older were living with Alzheimer's in 2023, and this number is projected to sharply increase to 13.8 million by 2060. The approval of Kisunla is seen as a crucial step in addressing this growing public health crisis.

Dr. Ronald Petersen, a neurologist at the Mayo Clinic, highlighted the significance of having multiple treatment options, stating, "It will give clinicians and patients a choice." The approval of Kisunla provides an additional tool in the fight against Alzheimer's, offering hope for improved quality of life for patients and their families.

Eli Lilly expects that once a patient's amyloid levels, a hallmark characteristic of Alzheimer's, have reached very low levels, treatment with Kisunla can be discontinued. However, the potential for amyloid to return and necessitate restarting treatment remains uncertain.

While the efficacy of Kisunla in slowing cognitive decline is encouraging, it is essential to note that, like other drugs in its class, there are potential life-threatening side effects. These include brain swelling and brain bleeding. Although most cases observed in the clinical trials were mild, the FDA reported that three deaths were linked to the drug.

Kisunla becomes the second monoclonal antibody drug of its kind to be FDA-approved, following the approval of Leqmebi. However, it's important to mention that a third drug, Biogen's Aduhelm, was taken off the market earlier this year.

The testimonial of Pat Bishara, a 79-year-old participant in the Kisunla clinical trials, provides some insight into the potential benefits of this new drug. Bishara, who was diagnosed with mild cognitive impairment in 2017, experienced no noticeable side effects during her participation and attributes her improved cognitive function to the treatment.

At a price of $32,000 for a 12-month supply, Lilly has set the cost of Kisunla. Medicare is expected to provide coverage for the drug, as the Centers for Medicare and Medicaid Services announced last year that it would pay for new Alzheimer's drugs granted full FDA approval. However, physicians will be required to collect real-world data on the drug's performance.

The FDA's decision on Kisunla was delayed earlier this year to obtain further guidance on weighing the benefits against the potential side effects. However, last month, the agency's advisory panel unanimously recommended the drug's approval, highlighting its potential impact on Alzheimer's patients.

It's hoped that the approval of Kisunla will mark a significant milestone in the fight against Alzheimer's, providing patients and their loved ones with a new treatment option that shows promise in slowing cognitive decline.