Hugel Resubmits Botulax BLA to FDA
Hugel expects to enter the U.S. market in first half of the 2023.
Hugel resubmitted the BLA for its botulinum toxin called Botulax for smoothing 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) 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, will be in charge of Hugel's U.S. sales and marketing of Botulax. Hugel appointed James P. Hartman as the president of Hugel America in May last year for a successful launching in the U.S. market. His 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.
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." says Jihoon Sohn, Hugel's CEO, in a news release.
Meanwhile, Hugel undertook Phase III of its clinical trials (BLESS 1,2) in 2015, aiming to launch its product in Korea 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.