Developing donanemab – balancing cost versus benefit
This article summarises recent regulatory developments surrounding the Alzheimer’s treatment donanemab and considers the future therapeutic market for this disease.
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This article summarises recent regulatory developments surrounding the Alzheimer’s treatment donanemab and considers the future therapeutic market for this disease.
The first new dementia medicine to be licensed in over two decades shows for first time, that the course of Alzheimer disease can be modified and slow cognitive decline.
From exciting data on cell therapy and monoclonal antibodies, through to new regulatory developments, this article summarises some of the key developments within the Alzheimer’s therapeutic landscape over July.
In its July meeting, the EMA’s human medicines committee recommended 14 medicines and held a negative opinion for authorising lecanemab to treat Alzheimer’s disease.
Despite some challenges, for the Alzheimer’s drug development pipeline, 2024 is a “learning year”, an expert on the disease says.
Part of Biogen’s prioritisation of its portfolio includes focusing on the advancement of its leading anti-amyloid beta Alzheimer’s treatment, LEQEMBI® (lecanemab-irmb).
In this article, Gareth Morgan, a life sciences partner at Pinsent Masons discusses how Leqembi validates the anti-amyloid approach for treating Alzheimer’s, and whether its recent regulatory authorisations could support fast-tracking approvals of other promising Alzheimer’s therapies.
A Marketing Authorisation Application for lecanemab to treat Alzheimer's has been submitted to the European Medicines Agency.
Lecanemab for Alzheimer's and the first potential gene therapy primed for US launch for haemophilia A are two potential blockbuster Drugs to Watch™, says a 2023 report.
Alzheimer’s drug Leqembi has been accepted via the US Food and Drug Administration (FDA)’s Accelerated Approval pathway.