US FDA declines to approve AbbVie’s wrinkle treatment due to manufacturing concerns (April 23)

(Corrects headline to say the FDA “declines” to approve the treatment and not “rejects”. Also corrects first bullet to say the treatment starts to work, not wears off, as early as 8 hours and removes comparison to Botox)

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 type of botulinum toxin designed to treat facial wrinkles such as frown lines. It starts to show effect as early as eight hours after administration and lasts for two to three 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)