{"id":67867,"date":"2023-10-02T12:47:42","date_gmt":"2023-10-02T16:47:42","guid":{"rendered":"https:\/\/ifintechworld.com\/investing\/eli-lilly-gets-fda-complete-response-letter-for-skin-treatment-after-inspection-of-third-party-facility\/"},"modified":"2023-10-02T12:47:44","modified_gmt":"2023-10-02T16:47:44","slug":"eli-lilly-gets-fda-complete-response-letter-for-skin-treatment-after-inspection-of-third-party-facility","status":"publish","type":"post","link":"https:\/\/ifintechworld.com\/?p=67867","title":{"rendered":"Eli Lilly gets FDA complete response letter for skin treatment after inspection of third-party facility"},"content":{"rendered":"
\n

Eli Lilly & Co. said Monday the U.S. Food and Drug Administration has issued a complete response letter for its lebrikizumab, a treatment for moderate-to-severe atopic dermatitis, after an inspection at a third-party manufacturer. The letter, which means the FDA cannot approve the drug for now, was based on findings from an inspection of a plant that included the monoclonal antibody drug substance for Lilly\u2019s lebrikizumab. \u201cThe letter stated no concerns about the clinical data package, safety or label for lebrikizumab,\u201d said Lilly, which is confident the data support its submission package for the medicine. The stock
\n LLY,
\n -1.76%<\/bg-quote>
\n fell 0.6% premarket but is up 47% in the year to date, while the S&P 500
\n SPX
\n has gained 11.7%. <\/p>\n<\/div>\n

Read the full article here<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Eli Lilly & Co. said Monday the U.S. Food and Drug Administration has issued a complete response letter for its lebrikizumab, a treatment for moderate-to-severe atopic dermatitis, after an inspection at a third-party manufacturer. The letter, which means the FDA cannot approve the drug for now, was based on findings from an inspection of a […]<\/p>\n","protected":false},"author":1,"featured_media":3941,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"video","meta":{"footnotes":""},"categories":[239],"tags":[83],"class_list":["post-67867","post","type-post","status-publish","format-video","has-post-thumbnail","hentry","category-investing","tag-featured","post_format-post-format-video"],"yoast_head":"\nEli Lilly gets FDA complete response letter for skin treatment after inspection of third-party facility | iFintechWorld<\/title>\n<meta name=\"description\" content=\"Eli Lilly & Co. said Monday the U.S. Food and Drug Administration has issued a complete response letter for its lebrikizumab, a treatment for\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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