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Commentary/Response to Damkier et al.
Pharmacoepidemiol Drug Saf
December 2024
Pharmacovigilance Risk Assessment Committee (PRAC), European Medicines Agency (EMA), Amsterdam, The Netherlands.
Lecanemab's Path Forward: Navigating the Future of Alzheimer's Treatment in Europe Amidst the EMA's Rejection.
Neurol Ther
November 2024
Memory Clinic and Neurodegenerative Dementia Research Unit, University Hospital Policlinico Tor Vergata, University of Rome "Tor Vergata", Viale Oxford, 81, 00133, Rome, Italy.
Lecanemab (Leqembi, Biogen), a humanized anti-amyloid-beta monoclonal antibody, has been approved for early-stage Alzheimer's disease (AD) in several countries, including the US and Japan. However, the European Medicines Agency (EMA) recently issued a negative opinion on its marketing authorization, reflecting concerns over the clinical value and manageability of anti-amyloid treatments. This decision highlights the ongoing disconnect between research advancements and clinical practice, where the focus on biological markers over tangible clinical improvements remains contentious.
View Article and Find Full Text PDFIndustry's perspective on challenges assessing the in vivo impact of removing titanium dioxide (TiO) from drug products.
J Pharm Sci
November 2024
Eli Lilly and Co. Synthetic Molecule Design and Development, 1223 W. Morris St., Indianapolis, IN, 46221, USA.
The European Commission (EC) has tasked the European Medicines Agency (EMA) to provide a recommendation towards the acceptability of titanium dioxide (TiO) in pharmaceutical products by early 2024 to inform on final decision in early 2025[1]. Unlike the already implemented ban of TiO in foods, removing this excipient from pharmaceutical products will likely have significant impact on the pharmaceutical industry, regulatory agencies, and patients. This commentary explores the challenges facing the pharmaceutical industry tasked with supporting the development and registration of TiO free (TF) drug products.
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