FDA requests more manufacturing data for AbbVie's botox alternative

AbbVie (NYSE: ABBV) received a Complete Response Letter from the U.S. Food and Drug Administration regarding its application for trenibotulinumtoxinE, a botulinum neurotoxin treatment for facial aesthetics.

The FDA requested additional information about manufacturing processes but did not identify safety or efficacy concerns and did not request additional clinical studies, according to the company's statement.

TrenibotulinumtoxinE is described as a first-in-class botulinum neurotoxin serotype E that begins working as early as 8 hours after administration and has a duration of 2-3 weeks. The treatment was evaluated in clinical studies involving over 2,100 patients, including two Phase 3 studies for moderate to severe glabellar lines.

"We strongly believe trenibotulinumtoxinE is an important innovation in botulinum toxin science, with the potential to expand options for patients interested in facial aesthetics," said Roopal Thakkar, executive vice president of research and development at AbbVie.

AbbVie expects to submit a response to the FDA's comments in the coming months. The company stated that regulatory reviews for the treatment in other countries are ongoing.

A Complete Response Letter indicates that the FDA has completed its review but requires additional information before approving the application.

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