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)

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