Letybo Earns FDA Approval, Hugel Expands Its Global Aesthetic Market Leadership

Letybo Earns FDA Approval, Hugel Expands Its Global Aesthetic Market Leadership

The global aesthetic medicine market was valued at $82.5 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 8.3 percent from 2024 to 2030.

Hugel, a Korean medical aesthetics company, recently announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its botulinum toxin, Letybo (letibotulinumtoxinA-wlbg), for the treatment of glabellar lines.

With this approval, Hugel becomes the first and only Korean company to have market approvals in all three major aesthetic markets: the US, Europe and China.

“We are thrilled with the FDA’s approval of Letybo. This is a huge achievement for Hugel as we focus on becoming a top aesthetics brand in the US,” said James Hartman, president of Hugel America in the news release. “As South Korea’s leading neurotoxin brand, our quality facial injectables are trusted by millions and we cannot wait to help even more people achieve their aesthetic aspirations.”

Glabellar lines emerge within the glabella, the area of skin situated between and above the eyebrows and directly above the nose. These lines manifest as a consequence of facial muscle activity beneath the surface, notably during expressions like talking, yawning, laughing or frowning. The glabella experiences muscle contractions that result in the inward squeezing of the forehead muscles, leading to the formation of these lines.

Initially, these lines might only be noticeable during specific facial expressions in youth, but over time, the surrounding tissue may develop persistent wrinkles.

Numerous doctors offer minimally invasive treatments aimed at reducing the visibility of frown lines. Among the most widely sought-after options are botulinum toxin injections, commonly referred to as Botox or Dysport. These injections function as neuromodulators: when administered into a muscle, they induce relaxation and restrict its movements, effectively diminishing the appearance of frown lines.

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How Does Letybo Work?

Letybo is classified as an acetylcholine release inhibitor and neuromuscular blocking agent. This prescription medication is injected into muscles and is intended for adults seeking temporary improvement in the appearance of moderate to severe glabellar lines situated between the eyebrows. It is specifically indicated for the temporary enhancement of these lines linked to the activity of the corrugator and/or procerus muscles in adult patients.

When administered intramuscularly at therapeutic dosages, Letybo functions by obstructing cholinergic transmission at the neuromuscular junction, thereby inhibiting the release of acetylcholine. As acetylcholine is blocked, muscle activity is temporarily reduced, leading to the diminished appearance of glabellar lines.

Efficacy and Safety of Letybo

FDA approval was granted based on encouraging outcomes from three completed Phase III trials, encompassing over 1,000 participants across the US and Europe. The primary efficacy endpoint, assessed at Week 4, demonstrated a significant improvement of at least 2 points from baseline at maximum frown, as evaluated using the Glabellar Line Scale (GLS).

The clinical investigation also investigated the safety profile of Letybo. Among patients receiving Letybo, the most commonly reported adverse reactions included headache, brow/eyelid ptosis (drooping) and blepharospasm (involuntary eyelid movements).

What Is the Price of Letybo?

Hugel is currently in the final stages of refining its go-to-market strategy, with plans to commercially launch Letybo soon, by mid-year. While Hugel has not disclosed the price for Letybo at this time, it is estimated that similar treatments, such as Botox Cosmetic, can range from $325 to $600.

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FDA-Approved Competitors in the Aesthetic Market

In 2022, the FDA granted approval for Daxxify (daxibotulinumtoxinA-lanm) for injection, designed to temporarily enhance moderate-to-severe frown lines (glabellar lines) in adults. Developed by Revance Therapeutics, Daxxify stands out for its composition, which is devoid of both human serum albumin and animal-based components.

Clinical trials revealed promising outcomes for Daxxify: 74 percent of participants witnessed a two-grade or greater improvement in glabellar lines by Week 4, as assessed by both investigators and patients. Furthermore, by Week 4, 98 percent of subjects displayed either none or mild wrinkle severity, according to investigator assessments.

Dysport (abobotulinumtoxinA), approved by the FDA since 2009, functions as an acetylcholine release inhibitor and a neuromuscular blocking agent. It is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity.

Clinical trials of Dysport revealed that treated subjects experienced treatment success, demonstrating a composite two-grade improvement in glabellar line severity at maximum frown by Day 30.

More Promising Phase III Trial Outcomes

Earlier this year, Galderma disclosed the results of its Phase III trial for relabotulinumtoxinA, demonstrating significant efficacy and prolonged duration of effect in treating glabellar lines and lateral canthal lines (crow’s feet), whether addressed individually or simultaneously.

The study revealed a minimum two-grade improvement in line severity post-treatment, with substantial response rates observed at one month: 94 percent to 96 percent reported none or mild frown lines, and 79 percent to 84 percent reported none or mild crow’s feet, whether treated singularly or concurrently. These findings further affirm relabotulinumtoxinA’s enduring efficacy, initially observed in prior trials.

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