In a news release, ProMIS Neurosciences Inc. (PMN:TSX; ARFXF:OTCQB) commented on the Nov. 6 meeting of the U.S. Food and Drug Administration's (FDA's) Peripheral and Central Nervous System Drugs Advisory Committee about Biogen's biologics license application for aducanumab as an Alzheimer's disease treatment.
The company noted that the final recommendation of the Peripheral and Central Nervous System Drugs Advisory Committee is negative, and though it is not binding, the FDA most likely will accept it. The committee members believed that the clinical data Biogen presented were inconsistent and, thus, one could not conclude from them that aducanumab is clinically effective.
"The key BLA components reviewed at the advisory committee meeting consisted of three clinical trials: two pivotal phase 3 trials of similar design (Study 301, 302) and one phase 1b trial (Study 103). Both Biogen and FDA acknowledged Study 301 (ENGAGE) was negative and could not contribute to the evidence for aducanumab’s effectiveness. Demonstration of effectiveness for licensing generally requires two adequate and well-controlled clinical trials that are positive. However, under certain circumstances and consistent with the 1997 FDA Modernization Act, FDA can conclude that one adequate and well-controlled clinical investigation plus confirmatory evidence is sufficient to establish effectiveness. Whether Study 302 (EMERGE) provided adequate evidence as a single study – a position strongly expressed by the FDA Office of Neuroscience – represented the key issue debated by the Advisory Committee," the ProMIS news release stated.
Dr. Billy Dunn, the director of the FDA's Office of Neuroscience, described EMERGE's results as "compelling," "exceptionally persuasive" and a "home run," ProMIS noted in the release. However, Dr. Tristan Massie from the Office of Biostatistics argued in his written review that one could not conclude the EMERGE study presented significant evidence due to the conflicts in the results from ENGAGE and EMERGE. Whereas Biogen had performed various subgroup analyses to determine why those two Phase 3 trials diverged in their results, but none revealed any clears reasons.
ProMIS' Chief Medical Officer Dr. James Kupiec wrote in the news release, "Although FDA will most likely accept the non-binding recommendations of the advisory committee, it is disappointing for patients, their caregivers and the research community that the committee viewed the inconsistencies in data as too significant to reach a conclusion that aducanumab is clinically effective."
"We are however encouraged by FDA's position on anti-Aβ antibodies. The amyloid hypothesis is far from dead now that the research community is focused on the most toxic molecular species, and we anticipate that PMN310, which selectively targets toxic amyloid beta oligomers, could demonstrate best-in-class effectiveness and safety in clinical studies," Kupiec added.
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