Hugel re-files BLA for Letybo with FDA after documental update

South Korea’s botulinum toxin maker Hugel has re-filed again for marketing clearance of its botox product Letybo with the Food and Drug Administration (FDA).

The resubmission follows the receipt of a Complete Response Letter (CRL) from the FDA in March 2022, which required additional data to complete the review of the company’s biological license application (BLA) filed last year.

Letybo is mainly used for cosmetic surgery such as improving glabellar lines.

Deficiencies cited by the FDA in the CRL are mainly associated with chemistry, manufacturing, controls, and general updates, according to the company.

The company expects to be able to launch the product in the U.S. in the first half of next year, as it usually takes about six months to obtain the FDA’s nod after submission. Local sales and marketing will be handled by Hugel America.

The U.S. is the world's single largest botox market and is one of the major markets that will propel Hugel’s global business growth after China and Europe. Hugel aims to become one of the top three toxin brands in the U.S. within three years.

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