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Solanezumab
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Solanezumab : ウィキペディア英語版
Solanezumab

Solanezumab (proposed INN) is a monoclonal antibody being investigated by Eli Lilly as a neuroprotector〔(International Nonproprietary Names for Pharmaceutical Substances (INN, prepublication copy) ), ''World Health Organization''.〕 for patients with Alzheimer's disease. The drug attracted extensive media coverage proclaiming it as a supposed "breakthrough" although in reality the medical evidence in support of such claims is lacking.
Solanezumab, or sola, binds the amyloid-β peptides that aggregate and form plaques in the brain that are an early pathological feature of Alzheimer's disease. Sola binds the central epitope of monomeric amyloid-β, KLVFFAD, (PDB ID 4XXD) with picomolar affinity. This epitope is known as the nucleation site for Aβ oligomerization, and it is these oligomers of Aβ that are thought to be toxic to neurons.
The two Phase III trials were EXPEDITION 1 and EXPEDITION 2. EXPEDITION 1 didn't meet the predefined assessments. Lilly changed the predefined study goal in EXPEDITION 2, but EXPEDITION 2 didn't meet that goal either.
An ex-FDA official told the Financial Times that solanezumab "does not have a snowball’s chance in a very hot place" of getting conditional approval. To the FDA, missing the primary endpoint in a Phase III trial is "fatal."〔
==References==



抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
ウィキペディアで「Solanezumab」の詳細全文を読む



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