FDA Greenlights Second Alzheimer’s Treatment, Kisunla, Despite Potentially Fatal Side Effects

FDA Approves Eli Lilly’s Kisunla

In a bid to slow down the progression of Alzheimer’s disease, the U.S. Food and Drug Administration (FDA) has given the nod to a second treatment known as donanemab or Kisunla. The drug, produced by pharmaceutical firm Eli Lilly, demonstrated a reduction in cognitive decline of around 22% compared to a placebo in a clinical trial involving 1,700 participants over an 18-month period.

Side Effects of Kisunla

However, the developers issued a warning that Kisunla is not without its risks. The most prevalent side effect identified during trials was brain swelling and bleeding, and three deaths were reportedly connected to the drug. However, despite these risks, the potential benefits of slowing cognitive decline in early stage Alzheimer’s patients have deemed the treatment worthwhile.

Anne White, Eli Lilly’s Executive Vice President, stated in a press release, “Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options.”

How Does Kisunla Work for Alzheimer’s Patients?

Kisunla specifically targets amyloid beta plaques in the brain, a key characteristic of Alzheimer’s disease. Patients involved in the trial had mild to early stage Alzheimer’s and received infusions of monoclonal antibodies every four weeks as part of their treatment.

Comparisons were drawn to the drug lecanemab (Leqembi), another Alzheimer’s treatment approved by the FDA last year. The drug, produced by Japanese firm Eisai, operates in a similarly targeting the amyloid plaques and similarly has potential side effects.

Price of the Alzheimer’s Treatment

A 12-month course of Kisunla is priced at approximately $32,000, which Medicare is expected to somewhat offset. When comparing this to the previously approved Leqembi, costing $26,500 for a year’s treatment, the latest medication does appear slightly more expensive.

However, the FDA has stated that once patients’ brain-plaque levels reach an almost undetectable threshold, the need for Kisunla treatments may halt which could potentially reduce the treatment costs.

“As a physician, I am encouraged by the potential to stop treatment, which could reduce out-of-pocket costs and infusion burden for eligible patients,” said Howard Fillit, co-founder of the Alzheimer’s Drug Discovery Foundation.

Battle Against Alzheimer’s

With no known cure for Alzheimer’s, an estimated 6.7 million Americans suffer from the disease, a number projected to increase to 13.8 million by 2060.

In light of these staggering figures, the approval of Kisunla gives a glimmer of hope to patients and the medical community. This comes especially after the withdrawal of Biogen’s medication Aduhelm earlier this year, with the company citing a decision to shift focus onto its collaboration with Eisai on Leqembi.

In conclusion, the approval of Kisunla brings hope to the battle against Alzheimer’s. Despite significant risks, the drug offers an alternative treatment option for early to mild Alzheimer’s, potentially slowing the cognitive decline witnessed in patients. The need for continuous treatment and its financial implication, however, remains a subject of ongoing debate. Nevertheless, each approval brings us a step closer to managing and potentially eliminating this devastating disease.

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