Aducanumab was originally designed to target amyloid-beta plaque, now believed to be an ineffective drug target for AD. An accumulating body of data has shifted the drug development focus to a different species of amyloid-beta called the toxic oligomer which has since been shown to be the real culprit in driving disease progression. Aducanumab’s ability to cross-react and partially neutralize toxic oligomers results in its modest treatment benefit. By contrast, published data show that PMN310, ProMIS’ antibody candidate for Alzheimer’s disease, is highly selective for the toxic oligomer of amyloid-beta, positioning it as a second-generation drug candidate with more precise targeting capabilities and a potentially improved safety and efficacy profile.
Despite aducanumab’s modest treatment benefit, the white paper argues that FDA approval is likely based on the following:
- FDA has encouraged Biogen to submit its application, granting it Priority Review; has endorsed continued clinical use of aducanumab in an open-label study, and; has demonstrated a willingness in the past to approve drugs despite limited data in instances where the unmet medical need is significant.
- Aducanumab’s phase 3 EMERGE trial was unequivocally positive and additional evidence for effectiveness is confirmed by results from the Phase 1b PRIME trial and subset data from the phase 3 ENGAGE trial.
- We anticipate the Advisory Committee members will most likely conclude that aducanumab’s data demonstrate the requisite “substantial evidence of effectiveness” and acceptable safety.
“Aducanumab represents a milestone treatment, and we applaud Biogen’s unrelenting commitment to its advancement,” said Dr.
The FDA’s Advisory Committee will be virtually convened and streamed via internet on
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