So, what can be said about the FDA's move to call in an advisory committee to review Lilly's drug application for Donanemab? First of all, a similar move was made during the Biogen/Eisai application for Lecanemab (LEQEMBI). However, at this late stage it was totally unanticipated by Lilly and the stock market. Predictably, LLY is down sharply today (shedding over $15 billion in market cap) on a day when Big Pharma stocks are up (despite Biden railing against prescription prices in the US last night) and BIIB is outperforming the group. The BIIB move is logical on the theory that it will have quite a few more months to establish LEQEMBI in the market before Donanemab is approved, assuming it actually is.
Beyond that, however, the publicity around this review (as well as the one currently being conducted on LEQEMBI by a Scientific Advisory Group for the EMA) is not helping the cause of monoclonal antibody treatment in the eyes of physicians and caregivers. LEQEMBI is already underperforming the initial targets set by Biogen/Eisai in the marketplace, and in recent special edition I noticed a poll taken by publisher "BioSpace" in which response to the question "Do you believe the current data show a benefit worthy of LEQEMBI's $26,500 price tag?" was 32% Yes, and 68% No.
In answer to sage4's question as to whether this is good timing (for Anavex) I would say it surely is. Both agencies, EMA and FDA, clearly have factions that are skeptical of the benefit to cost ratio - cost including safety, convenience of administration, and expense. Whether they approve LEQEMBI or Donanemab, respectively, or whether they don't, it seems that the outcomes will have been contentious. The physicians who prescribe for Alzheimer's patients by now fully recognize that there are significant limitations to what mAb therapy has offered up so far. The appearance of a drug application for Blarcamesine with a different solution (in a pill) that matches or exceeds the efficacy of mAb's in a shorter period of time, eliminates the risk of serious side effect, and slows brain shrinkage instead of accelerating it, will be taken very seriously at both agencies. (I didn't even mentioned the claimed benefits of better sleep, reduced blood pressure, improved tau levels and reduced inflammation, where we haven't seen the data yet.) So, yes, I think the timing of these calls for advisory groups, which is sparking renewed controversy over the mAb's in the press, coupled with apparently lackluster LEQEMBI sales, is very beneficial for Anavex's cause.
