What the sponsor asked the agency to accept
As the FDA restates it.
We acknowledge that you have tried to meet the exposure requirements through a “treatment protocol” approach based on the dosage regimen of Kisunla specified in the protocol, in which the Kisunla dose was either reduced or stopped when amyloid beta plaque measurements declined to a pre-specified threshold on PET imaging.
Complete response letter · PDF p. 2 · action of · fda.gov ↗ · scanned page, OCR-checked
What the agency said
T4 · DataConsistent
DON-T4-1
The safety database is insufficient to adequately characterize the long-term safety of Kisunla in the treatment of Alzheimer’s disease.
Complete response letter · PDF p. 2 · action of · fda.gov ↗ · scanned page, OCR-checked
Compared to ADU-T4-3, Aduhelm, accelerated approval, .
T4 · DataConsistent
DON-T4-2
Your BLA submission contains data for only 49 patients who were exposed to Kisunla at the highest proposed dosage regimen (700 mg for 3 doses followed by 1400 mg thereafter) for 12 months.
Complete response letter · PDF p. 2 · action of · fda.gov ↗ · scanned page, OCR-checked
Compared to ADU-T4-3, Aduhelm, accelerated approval, .