With piv­otal da­ta on its Covid-19 an­ti­body in hand, As­traZeneca pre­pares for a mad dash to the FDA

A month af­ter re­veal­ing that its mon­o­clon­al an­ti­body com­bi­na­tion was 77% ef­fec­tive at pre­vent­ing symp­to­matic Covid-19 com­pared to place­bo, As­traZeneca says it’s head­ed to the FDA.

“We’ve cer­tain­ly shared the da­ta with reg­u­la­tors, and we an­tic­i­pate sub­mit­ting the emer­gency use au­tho­riza­tion very short­ly,” Mark Ess­er, VP and head of mi­cro­bial sci­ences and bio­phar­ma­ceu­ti­cals R&D, said dur­ing a press con­fer­ence on Wednes­day af­ter­noon.

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