In a news release, ProMIS Neurosciences Inc. (PMN:TSX; ARFXF:OTCQB) announced that it composed a white paper explaining why it believes the U.S. Food and Drug Administration (FDA) will likely approve Biogen's aducanumab when it comes up for review on Nov. 6, 2020.
If the biopharma is correct and the regulatory agency's advisory committee approves aducanumab, it will be the first treatment for patients with Alzheimer's that actually alters the disease, the company noted.
"Aducanumab represents a milestone treatment, and we applaud Biogen's unrelenting commitment to its advancement," ProMIS Neurosciences President and CEO Dr. Elliot Goldstein said in the release.
ProMIS' primary arguments for likely approval are that:
1. The FDA encouraged Biogen to submit an application for aducanumab and afforded it priority review status. The agency approved the continued clinical use of aducanumab in an open-label study and historically has been willing to approve drugs in cases of significant unmet medical need but limited data.
2. The Phase 3 EMERGE trial of aducanumab was undoubtedly positive. Results from two additional studies, Phase 1b PRIME and Phase 3 ENGAGE, confirm the drug's efficacy.
3. The advisory committee members will likely find that aducanumab meets the requisite threshold for approval because accumulated trial data show significant efficacy and safety.
ProMIS' white paper, available on its website, provides aducanumab's history, positive data and regulatory support and explains why the drug may spur development of better second-generation therapies.
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