Lecanemab will be approved by FDA in July, next PBT2????

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee on Friday voted 6-0 in favor of fully approving Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab), which first won an accelerated approval in January.

Now Prof Masters need to do the same with PBT2, with no brain swelling or brain bleeds, everything in a similar selected population as was done with Lecanemab.

In the Lannfelt et al study (2008) PBT2 the positive effect on cognition was seen in 3 months and in reanalysis by Faux et al this difference became even more substantial. The treated cases were "early AD" cases. In the Imagine study for inclusion, the usual clinical criteria for prodromal or probable AD, Mini-Mental State Examination ≥20 (as in the Lannfelt study), and global Pittsburgh compound B (PiB)-PET standardized uptake volume ratio (SUVR) >1.7 were used. IMO the last criterion was the mistake as the authors indicate "Small numbers, large variances, and higher than expected mean baseline standardized uptake volume ratio may have contributed to lack of demonstrable efficacy".

Now there are better biochemical indicators of early AD. Lecanemab studies used these and got results in 18 months. It slowed the AD process by 27%. In Lannfelt et al study PBT2 demonstrated efficacy already in 3 months with an oral drug with no side effects and it improved cognition, not only stopping the progression. In the Faux et al paper: "PBT2 rapidly improves cognition in Alzheimer's Disease: additional phase II analyses".

Masters wants to correct his "mistake" in patient selection and he knows now how!

Read more about approval of Lecanemab: https://endpts.com/fda-adcomm-votes-unanimously-in-favor-of-full-approval-for-eisais-new-alzheimers-drug/