Hugel Resubmits BLA for Its Botulinum Toxin Letybo to the US FDA

Hugel, BLA submission, Botulinum Toxin, Letybo, glabellar lines, crow feet

Hugel has just rekindled its pursuit of a groundbreaking achievement: the approval of Letybo (letibotulinumtoxinA), a potent botulinum toxin, for the treatment of those pesky glabellar lines, commonly known as frown lines from the United States Food and Drug Administration (FDA).

Hugel had boldly submitted a Biologics License Application (BLA) for Letybo back in October 2022, filled with hope and anticipation. However, the FDA responded with a twist in the plot—a Complete Response Letter (CRL). This was a setback, but Hugel wasn’t one to be deterred. Instead, they embarked on a mission to address the FDA’s concerns, taking a deep dive into their facility management and carrying out supplementary work that aligned with the FDA’s requests.

And so, on August 31st (local time), Hugel re-entered the fray, resubmitting the BLA with a renewed spirit and a meticulous approach. The journey was not without its challenges, but every twist and turn served as a stepping stone toward their ultimate goal: FDA approval.

But what does this mean for those eagerly waiting for Letybo? Well, patience is key. From the moment a BLA is submitted, it typically takes around six months to secure that coveted marketing approval. If all goes as planned, Letybo could be a shining star in the medical aesthetics sky by the first quarter of 2024, potentially transforming the landscape for individuals seeking a smoother, more youthful appearance.

“The US is the world’s single largest botulinum toxin market and considered one of the big three global markets along with China and Europe, where Hugel operates. We remain committed to become a leading company in the global botulinum toxin industry through the successful launch of Letybo into the US market.”

– Hugel

But why all the fuss about Letybo? It’s not just any botulinum toxin; it’s a reigning champion. In its native South Korea, it holds the throne as the No. 1 product in the botulinum toxin market, a testament to its efficacy and trustworthiness. Not content with dominating the Korean scene, Letybo has embarked on a global odyssey, capturing the imaginations of individuals in China, Europe, and Australia. It proudly boasts the title of the first Korean toxin brand to expand beyond its homeland.

The Canadian market, too, has welcomed Letybo with open arms, granting approval in June of the previous year. Now, it eagerly awaits its commercial debut, a development poised to elevate the standards of aesthetic care in the region.

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