Hugel resubmits BLA for its botulinum toxin, Botulax to the U.S. FDA

Hugel resubmits BLA for its botulinum toxin, Botulax to the U.S. FDA

Hugel received CRL from the U.S. FDA last March and completely supplemented documents and data. It is expected to obtain the U.S. FDA’s approval in the first half of 2023 and aims to become a TOP 3 botulinum toxin brand in the U.S. market.

SEOUL, South Korea, Oct. 8, 2022 /PRNewswire/ — Hugel (CEO Jihoon Sohn), a global total medical aesthetics company, announced that it resubmitted the BLA for its botulinum toxin called Botulax on October 6th (local time), for the indication of glabellar lines to the U.S. FDA.

Hugel had received a Complete Response Letter (CRL) from the U.S. FDA last March after submitting the BLA for Botulax (50 and 100 units) in order to advance into the U.S. market in March of last year.

The company sent supplemental documents and data based on requests set out in the CRL and resubmitted the BLA to the U.S. FDA. As it takes around six months to obtain the marketing approval from the period of BLA submission, Hugel expects to enter the U.S. market in first half of the 2023. 

Hugel America, a U.S. subsidiary which will be in charge of Hugel’s U.S. sales and marketing of Botulax. Hugel appointed James P. Hartman, a seasoned expert in the medical aesthetic field, as the president of Hugel America in May last year for a successful launching in the U.S. market. He’s aim is to make Botulax the TOP 3 brand in the U.S. market within three years of the launch by establishing an aggressive marketing strategy for a fast market penetration.

In order to accelerate its market expansion into the U.S., Hugel also appointed that Brent L. Saunders, the former CEO and chairman of global medical aesthetic company Allergan (currently, Abbvie), as the chairman of the board of directors last June and has recently proceeded with the validation after completing the construction of a third factory of botulinum toxin.

“The U.S. is the world’s largest single botulinum toxin market, and will become one of the key markets for Hugel to achieve a great leap forward as it has done in China and Europe. As we are in the final stage for advancement into the U.S. market, we will do our best to successfully launch Botulax and ensure that it becomes one of the top three brands in the U.S. market within three years from its launch.” said Jihoon Sohn, Hugel’s CEO.

Meanwhile, Hugel undertook Phase III of its clinical trials (BLESS 1,2) in 2015, aiming to launch its product in the KRW 2 trillion U.S. botulinum toxin market, and officially completed clinical trials in 2019. It submitted a BLA in April of last year, and undertook on-site due diligence at its Geodu factory in August.

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