FDA Gives Approval to Alzheimer’s Drug Donanemab Following Months of Waiting

Breakthrough Alzheimer’s Drug Approval

The FDA Approves Game-Changing Alzheimer’s Drug

Unprecedented FDA Approval

The Food and Drug Administration has granted approval to a groundbreaking Alzheimer’s drug, emphasizing that the benefits of modestly slowing down the progression of the disease far outweigh any risks involved, as announced by drugmaker Eli Lilly.

Positive Endorsement

Receiving a unanimous endorsement from a panel of independent experts last month, the FDA’s approval of Eli Lilly’s Kisunla, also known as donanemab, marks a significant milestone. The drug is one of the rare treatments that directly modifies the underlying disease of Alzheimer’s, joining Leqembi as the sole options available in the market.

Effective Treatment

Kisunla, approved for treating early symptomatic Alzheimer’s disease, although not a cure, has been proven to slow cognitive and functional decline in patients. The drug works by clearing amyloid beta, a sticky plaque in the brain linked to the disease.

Impacts of the Drug

The clinical trial revealed a remarkable 35% decrease in cognitive and functional decline over 18 months in patients with mild cognitive impairment. Additionally, Eli Lilly is exploring the drug’s potential to prevent Alzheimer’s in individuals not showing symptoms by clearing amyloid.

Cost and Availability

Costing around $32,000 for a full year of treatment, Kisunla’s price may vary depending on when the patient completes the therapy. Medicare is expected to provide coverage for certain patients, potentially reducing the out-of-pocket expenses.

Controversies and Success

Despite facing controversies and risks, including three deaths during clinical trials, the FDA’s approval of donanemab signifies a significant advancement in Alzheimer’s treatment. With the potential to modify the disease’s course, the drug offers hope for those affected by Alzheimer’s.

Future Endeavors

With the drug’s administration requiring monthly infusions, Eli Lilly’s innovative approach enables treatment discontinuation upon reaching a certain amyloid level. This feature could alleviate the burden on patients, although procedures for amyloid testing remain uncertain.

Read More of this Story at www.washingtonpost.com – 2024-07-02 23:51:37

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