FDA re­jects Eli Lil­ly’s eczema drug due to third-par­ty man­u­fac­tur­ing is­sues 

FDA has re­ject­ed Eli Lil­ly’s eczema treat­ment le­brik­izum­ab due to is­sues found at an un­named third-par­ty man­u­fac­tur­er.

Ac­cord­ing to a press re­lease, a “mul­ti-spon­sor” in­spec­tion found is­sues at the man­u­fac­tur­er, in­clud­ing ones re­lat­ing to the mon­o­clon­al an­ti­body drug sub­stance for Lil­ly’s le­brik­izum­ab. The com­plete re­sponse let­ter did not state any con­cerns with safe­ty or la­bel­ing for le­brik­izum­ab, the com­pa­ny wrote.

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Life Sciences Senior Associate

General Catalyst

San Francisco, CA, USA