CNS

Eisai has spent 25 years looking for a breakthrough in Alzheimer’s and warns that healthcare systems need to undergo a major shift to accommodate its breakthrough drug.

Scrip surveys the Phase III clinical trial readout landscape and picks 10 of the more interesting studies set to report in 2023, with a few added extras. AstraZeneca, Novo Nordisk, Novartis and Roche feature heavily.

The US firm is touting top-line data from an open-label Alzheimer’s disease trial as a net positive, but the lack of p-values and a declining trend in efficacy left some investors and analysts lukewarm.

Lilly plans to seek traditional approval for its amyloid-clearing antibody after the Phase III TRAILBLAZER-ALZ 2 trial reads out in Q2, but it loses important ground in reimbursement negotiations.

Despite being hailed as a potential breakthrough for Alzheimer’s, the EMA will not fast-track lecanemab, underscoring differences with the FDA’s frequent use of accelerated pathways.

The Swedish firm’s Parkinson's disease drug has failed to hit its primary endpoint in a Phase IIb study but Irlab believes that positive results on secondary goals merit further development of mesdopetam.

New CEO Bill Meury said Karuna had plenty of time, money and physician enthusiasm to ensure a US launch in 2024 would be a success.

In this week's podcast version of Five Must-Know Things: major trends and deals from the recent J.P. Morgan meeting, the impact of the US Inflation Reduction Act, the pricing of Alzheimer’s drug Leqembi and five blockbusters set to lose exclusivity this year.

The US biotech’s candidate, ALTO-100, has hit the mark in a Phase IIa depression trial, de-risking the firm’s novel precision approach to psychiatry R&D and triggering the start of a Phase IIb study.

Eisai and Biogen’s aducanumab was never approved in the European Union and while lecanemab is generating more confidence, a fast track review has not yet been confirmed.

The Belgian group’s older products helped push 2022 revenues to the top of their guidance range as the peak sales forecast for the new epilepsy drug Fintepla is set at €800m.

Mitsubishi Tanabe Pharma paid $1.1bn to acquire the Israeli biotech in 2017 for a drug that analysts forecast to represent a market opportunity worth up to $1.7bn in peak sales.