US FDA rejects AbbVie’s wrinkle treatment due to manufacturing concerns

By Padmanabhan Ananthan

April 23 (Reuters) – AbbVie said on Thursday the U.S. Food and Drug Administration has declined to approve its experimental wrinkle treatment, trenibotE, citing issues in manufacturing.

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.

(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Vijay Kishore)