Hit­ting a new record on drug ap­provals, the FDA of­fers a thumbs-up to an­oth­er atopic der­mati­tis con­tender

Five years af­ter lit­tle Leo Phar­ma put up its dukes and $115 mil­lion in cash to ac­quire and ad­vance tralok­inum­ab for atopic der­mati­tis, the Dan­ish biotech has crossed the reg­u­la­to­ry fin­ish lines with a year-end ap­proval at the FDA.

The drug will be sold as Ad­bry and there’s no im­me­di­ate word on pric­ing.

This is the 50th new drug ap­proval from CDER this year, tot­ting up to 60 for the year if you add 10 ma­jor bi­o­log­ic OKs to the mix. That marks a record num­ber of new ap­provals from the agency, tip­ping the scales af­ter hit­ting 59 in 2020 and 2018. And it’s an in­di­ca­tion that de­spite a long litany of set­backs in CMC in oth­er ar­eas, the drum­beat of new ap­provals con­tin­ues at chart-top­ping lev­els af­ter the long and dis­as­trous dry spell of the ear­ly 2000s — de­spite a glob­al pan­dem­ic.

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