I’m guessing the FDA won’t be tripping over themselves to approve this.
Eisai, Biogen's injectable Leqembi clears toxic protein in Alzheimer's disease. What about safety? | Fierce Pharma
https://www.fiercepharma.com/pharma...-protein-alzheimers-disease-what-about-safety
“Despite the positive efficacy data, a closely watched safety measurement raised some eyebrows. But analysts argued the readout shouldn’t be a concern.
Specifically, subcutaneous Leqembi showed a numerically higher rate of amyloid-related imaging abnormalities (ARIA), a known side effect of anti-amyloid antibodies like Leqembi. The rates of brain swelling, known as ARIA-E, were 16.7% and 12.6% for subcutaneous (SC) and intravenous (IV) Leqembi, respectively. The rates of small brain bleedings, known as ARIA-H, were 22.2% and 17.3%, respectively.”
Eisai, Biogen's injectable Leqembi clears toxic protein in Alzheimer's disease. What about safety? | Fierce Pharma
https://www.fiercepharma.com/pharma...-protein-alzheimers-disease-what-about-safety
“Despite the positive efficacy data, a closely watched safety measurement raised some eyebrows. But analysts argued the readout shouldn’t be a concern.
Specifically, subcutaneous Leqembi showed a numerically higher rate of amyloid-related imaging abnormalities (ARIA), a known side effect of anti-amyloid antibodies like Leqembi. The rates of brain swelling, known as ARIA-E, were 16.7% and 12.6% for subcutaneous (SC) and intravenous (IV) Leqembi, respectively. The rates of small brain bleedings, known as ARIA-H, were 22.2% and 17.3%, respectively.”