FDA paves way for full approval of new Alzheimer's drug
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A Food and Drug Administration (FDA) advisory committee has unanimously voted to confirm the clinical benefits of Leqembi, the second such drug to target the fundamental pathophysiology of Alzheimer’s.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCN) approved the data from Phase 3 Clarity AD clinical trial of Leqembi 100 mg/mL injection for intravenous use, said Eisai’s press release.
This vote paves the way for a full agency approval. Created by Japanese pharmaceutical company Eisai and American biotechnology company Biogen, Leqembi was earlier approved under FDA’s accelerated approval pathway in January 2023. The FDA instituted the accelerated approval process in 1992 because measuring a drug’s medical benefits takes a long time and when there’s an urgent need for such a life-saving drug, then the process has to be expedited.
The Prescription Drug User Fee Act (PDUFA) action date is set for the traditional approval of Leqembi on July 6, 2023.
In earlier trials, it was found that Leqembi could delay cognitive decline by 27 percent. The patients in the treatment group experienced a noticeable decrease in amyloid beta plaques, a sign of Alzheimer’s disease, as the dosage and duration of the treatment increased.
But the drug and the drug manufacturers found themselves in a fix when three deaths were reported during clinical trials. Axios reported that the FDA staff said that the safety concerns "do not appear to preclude traditional approval," though they could not rule out the drug's role in the deaths.
Additionally, there is a risk of infusion-related reactions with Leqembi, which can cause flu-like symptoms, nausea, vomiting, and changes in blood pressure. The most frequently reported side effects of Leqembi are infusion-related reactions, headaches, and ARIA (brain swelling).
Alzheimer’s mostly affects the population above the age of 65, although recently a 19-year-old in China became the youngest person in the world to be diagnosed with Alzheimer's. Alzheimer’s disease kills people more than breast cancer and prostate cancer combined and millions are spent every year on scientific research to find a cure for Alzheimer’s.
Colette Johnston, one of the advisers of the committee, said in an interview with Axios that some groups of patients will have more concerns that should be addressed with their physicians, but the overall risk-benefit was “very positive.”
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