AbbVie TrenibotE: FDA Rejects BLA Over Manufacturing Issues FDA issued Complete Response Letter. AbbVie's TrenibotE BLA rejected. Manufacturing process concerns cited. No new clinical trials requested. AbbVie's trenibotulinumtoxinE (TrenibotE) Biologics License Application (BLA) received a Complete Response Letter (CRL) from the FDA. The rejection stems from identified issues within the manufacturing process, not clinical efficacy or safety data. TrenibotE, a prospective competitor to Botox, was in late-stage development. This setback delays its entry into the highly competitive neurotoxin market. The FDA's CRL indicates significant Chemistry, Manufacturing, and Controls (CMC) deficiencies. Under 21 CFR 314.110, a CRL outlines reasons for non-approval. AbbVie must address all manufacturing concerns and resubmit a revised BLA. This process typically involves facility inspections and detailed data submission. The EMA has not yet issued a decision for TrenibotE, with its review ongoing. This rejection benefits current market leaders like Allergan's Botox and Evolus's Jeuveau. AbbVie's delay provides competitors more time to solidify market share. The company will now focus on resolving the manufacturing issues. A resubmission timeline remains undisclosed, but market entry is unlikely before late 2027.