FDA hits Leo Phar­ma with a CRL for what the biotech says are ques­tions about the 'de­vice com­po­nen­t' of eczema can­di­date

Af­ter toil­ing away for the last few years on a mon­o­clon­al an­ti­body to com­pete with Dupix­ent in atopic der­mati­tis, Leo Phar­ma has been hit with a com­plete re­sponse let­ter from the FDA.

The agency has “re­quest­ed ad­di­tion­al da­ta re­lat­ing to a de­vice com­po­nent of tralok­inum­ab,” Leo said on Thurs­day, but the biotech didn’t share any fur­ther de­tails on the de­vice or what went wrong. Com­pa­ny spokesper­son Hen­rik Kyn­dlev de­clined to pro­vide more in­for­ma­tion via email, but said Leo is “look­ing for­ward to meet with the FDA to clar­i­fy de­tails about the re­quest.”

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