Boosted by his firm’s positive Phase III presentation at last week’s ATTR meeting, Alnylam Pharmaceuticals’ (Nasdaq: ALNY) EVP of research and development Akshay Vaishnaw won’t commit to saying that regulatory approval is inevitable, but he and president Barry Greene certainly give that impression.
Given the strength of the data - including a safety profile which Ionis Pharmaceuticals’ (Nasdaq: IONS) rival therapy inotersen has been unable to match - their confidence seems well placed.
Dr Akshay and Mr Greene say they will submit for approval in the USA and European Union this year, with a decision expected by the middle of 2018.
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