AbbVie Faces Setback as USFDA Declines Approval of Wrinkle Drug TrenibotE

Here are some details:

• TrenibotE is ​a botulinum toxin for treating facial ​wrinkles such as frown lines, with effects ⁠wearing off as early as 8 hours ​compared to Botox's duration of over two ​weeks.
• The setback removes a near-term catalyst for AbbVie’s aesthetics business, but Street expectations for trenibotE were modest, Citi ​analyst Geoff Meacham said.
• Meacham also noted ​that manufacturing‑related requests have likely delayed approval into 2027.
• AbbVie ‌added ⁠the agency did not raise concerns about the treatment's safety or efficacy, and did not ask for new patient studies.

• The company dominates ​the aesthetics ​market, generating ⁠multi-billion-dollar revenues from its Botox treatment, which are used for wrinkle ​smoothing, migraines and muscle disorders.
• The company ​said ⁠trenibotE has been studied in more than 2,100 patients, including two late-stage trials and a ⁠safety ​study.
• AbbVie said regulatory reviews of ​the treatment in other countries are still underway.