Eli Lil­ly will use a pri­or­i­ty re­view vouch­er on Moun­jaro to 're­move any un­cer­tain­ty' around fast FDA re­view

Eli Lil­ly isn’t wait­ing around for the FDA’s fast-track path­way. The team is “fever­ish­ly” sub­mit­ting its new Phase III da­ta for Moun­jaro in obe­si­ty, and will use a pri­or­i­ty re­view vouch­er to cut four months off of the stan­dard re­view time.

That could line up a po­ten­tial ap­proval as ear­ly as the end of this year, ex­ec­u­tive VP and Lil­ly Di­a­betes pres­i­dent Mike Ma­son said on the com­pa­ny’s first quar­ter earn­ings call. A rolling sub­mis­sion is al­ready un­der­way with da­ta re­leased in 2022, and Lil­ly ex­pects to com­plete the ap­pli­ca­tion in the com­ing weeks.

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