Key insights
- The FDA rejected AbbVie's wrinkle treatment, TrenibotE, due to manufacturing issues, not safety or efficacy. This is a minor negative for AbbVie as it delays potential revenue from this product. The lack of safety/efficacy concerns and no requirement for new trials suggests a resolution is possible, limiting the long-term impact.
April 23 (Reuters) - AbbVie said on Thursday the U.S. Food and Drug Administration has declined to approve its experimental wrinkle treatment, citing issues in manufacturing.
The company said the agency did not raise concerns about the treatment's safety or efficacy, and did not ask for new patient studies.
TrenibotE is a fast‑acting botulinum toxin aimed at treating facial wrinkles such as frown lines, and it is designed to wear off more quickly than traditional Botox treatments.
The company said the treatment has been studied in more than 2,100 patients, including two late-stage trials and a safety study.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Vijay Kishore)