Blue­bird’s new gene ther­a­py among three new EMA OKs ahead of FDA

Ahead of a usu­al­ly speedy FDA, the Eu­ro­pean Med­i­cines Agency on Fri­day rec­om­mend­ed mar­ket­ing au­tho­riza­tions for blue­bird bio’s new gene ther­a­py for chil­dren with a rare, in­her­it­ed neu­ro­log­i­cal dis­ease, Glax­o­SmithK­line and Vir’s mon­o­clon­al an­ti­body treat­ment for Covid-19, and a new treat­ment for a rare liv­er dis­ease.

In the case of blue­bird’s Skysona (eli­v­al­do­gene au­totem­cel), the gene ther­a­py is for those younger than 18 who have what’s known as ear­ly Cere­bral Adrenoleukody­s­tro­phy (CALD). If un­treat­ed, near­ly half of those with CALD die with­in 5 years of symp­tom on­set, EMA said.

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