Food And Drug Administration Approved Kisunla Medicine

The FDA (Food and Drug Administration) has approved Eli Lilly’s new drug Kisunla. During the trial, the medicine effectively slowed a decline in memory and thinking abilities. The name of the drug is Donanemab, which will be sold under the brand name, Kisunla. It’s a monoclonal antibody infusion given to patients in two weeks. 

The FDA’s approval of Kisunla, a new drug from Eli Lilly, marks a significant advancement in the treatment of Alzheimer’s disease. The drug, designed for use in adults with mild cognitive damage or early Alzheimer’s disease, targets amyloid, a protein believed to be toxic to brain cells. 

Dr Ronald Petersen, a neurologist at the Mayo Clinic, said that this approval is of major importance because now there is another treatment option for Alzheimer’s. Peterson said, “ It will give clinicians and patients a choice.” Last Summer, the Food and Drug Administration approved Leqembi, a similar drug. 

The Alzheimer’s Association revealed that around 6.7 million Americans aged 65 or more were diagnosed with Alzheimer’s in 2023, and the number is expected to reach 13.8 million by 2060.

The approval was based on a clinical trial of 1,700 Alzheimer’s patients. After 18 months, the drug slowed the progression of the disease by 35%. A clinical dementia rating scale measured the drug’s performance. This device focuses on patients’ performance in six categories: orientation, judgement and problem-solving, community affairs, memory,  personal care, and hobbies. 

Eli Lilly mentioned in a statement that once a patient’s amyloid levels reach very low levels, the treatment can be stopped. Amyloid can return at any time later, and when it does, the patient can restart the treatment. 

Like every other drug, Kisunla also has some life-threatening side effects. It can cause poor brain health, swelling, and bleeding. According to the FDA, most cases in the trials were mild, but there were three deaths linked to the drug.