FDA Decision on AbbVie’s Treatment#
AbbVie announced on Thursday that the U.S. Food and Drug Administration (FDA) has declined to approve its new wrinkle treatment. The FDA cited concerns related to the manufacturing processes involved in producing the treatment, rather than any issues regarding safety or effectiveness.
About the Treatment#
The treatment in question, known as trenibotulinumtoxinE, is a type of botulinum toxin that can start showing results as soon as 8 hours after administration. Its effects can last for 2 to 3 weeks. AbbVie conducted clinical studies involving over 2,100 patients, including two Phase 3 studies focused on treating moderate to severe glabellar lines, which are the wrinkles between the eyebrows.
AbbVie’s Response#
Roopal Thakkar, AbbVie’s executive vice president of research and development, expressed confidence in the treatment, stating that it represents a significant advancement in botulinum toxin science and could provide more options for patients seeking facial aesthetic treatments.
Next Steps for AbbVie#
AbbVie plans to address the FDA’s comments and submit additional information in the coming months. Meanwhile, the company is also pursuing regulatory reviews for the treatment in other countries.