Hugel Challenges Botox with FDA Approval for Neurotoxin Injection for Frown Lines

Botox_iStock, macniak

Pictured: Doctor injecting Botox into the forehead of a woman/iStock, macniak

The FDA on Monday approved Hugel America’s neurotoxin injection letibotulinumtoxinA-wlbg, now to be marketed as Letybo, for the treatment of glabellar lines—frown lines that appear in between the eyebrows—in adults.

With the FDA’s greenlight, Hugel will now “accelerate” the transition to approved medical use, the company noted in its announcement. Hugel expects to launch Letybo in aesthetic centers in the U.S. in the latter half of 2024.

Hugel America President James Hartman in a statement called Letybo the “leading neurotoxin brand” in South Korea, which is one of the most dynamic and active aesthetics markets in the world. The company, Hartman said, is “thrilled” with the approval which will help Hugel become a “top aesthetics brand in the U.S.”

The FDA’s approval of Letybo is backed by data from three Phase III trials, which together involved more than 1,200 participants across various sites in the U.S. and Europe. According to its label, Letybo was able to elicit significant treatment success across all three studies, defined as none or mild glabellar lines and an improvement of at least two points on the Glabellar Line Scale versus baseline.

Letybo’s label also carries a boxed warning for the distant spread of its toxin effect to other body parts, which may occur within hours to weeks after administration. “Swallowing and breathing difficulties can be life threatening and there have been reports of death,” the label read.

Monday’s approval represents a triumphant culmination of Letybo’s rough regulatory road. The pharma first filed its Biologics License Application in 2021 but was rejected by the FDA in March 2022, with the regulator asking for additional data including chemistry, manufacturing and controls. Hugel resubmitted its application in October 2022, which the FDA accepted the same month.

However, the FDA again denied approval in 2023. Hugel made another resubmission in September 2023 following a review of its facility management as well as other supplementary work to address the FDA’s concerns.

With Letybo entering the U.S. market, Hugel is poised to challenge AbbVie’s blockbuster neuromuscular blocker Botox (botulinum toxin), which made more than $2.9 billion in global net revenues in 2023.

Another strong competitor is Revance Therapeutics, whose Daxxify (daxibotulinumtoxinA-lanm) was approved in September 2022 for moderate-to-severe frown lines. At the time, the biotech touted Daxxify as the “first and only peptide-formulated neuromodulator with long-lasting results.” In Daxxify’s Phase III development program, its efficacy had a median duration of six months, with some patients even seeing maintained results up to nine months.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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