The landmark FDA approval of Biogen / Eisai’s aducanumab (Aduhelm) in 2021 has had a minimal effect on treatment dynamics in AD owing to the lack of reimbursement and the controversy surrounding its approval. Eisai / Biogen’s lecanemab (Leqembi) became the second FDA-approved anti-Aβ MAb in January 2023, following its accelerated approval for early AD; applications for traditional FDA approval as well as for approval in Europe and Japan have been accepted by regulators. Other DMTs may soon follow in the United States and potentially other markets (Eli Lilly’s donanemab, and Novo Nordisk’s semaglutide). Meanwhile, in May 2023, Lundbeck / Otsuka’s Rexulti became the first therapy to receive FDA approval for AD agitation. That said, therapies from Otsuka, BioXcel, and Axsome are progressing through late-phase development to treat key neuropsychiatric symptoms associated with AD. The launch of these potential blockbusters could meaningfully alter the dynamics of this market, driven by clear need, strong market demand, and premium pricing.
Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.
Disease Landscape & Forecast will be updated throughout the year to provide timely insights and analyses as material indication-specific news and events unfold.
Disease Landscape & Forecast features a Drug Pipeline chapter with real-time, global pipeline intelligence content directly from Cortellis. This chapter is updated daily and features interactive figures that can be easily downloaded for detailed analysis or presentations.