Hugel fails to get FDA approval for botulinum product

The Korea Times

The Korea Times

Business

Tue, September 26, 2023 | 08:46

Bio

Hugel fails to get FDA approval for botulinum product

Posted : 2023-04-19 16:34

Updated : 2023-04-20 12:18

Cha Suk-yong, executive chairman of Hugel / Courtesy of Hugel

By Baek Byung-yeul

Hugel, a local botulinum toxin (Botox or BTX) maker, is facing a setback in its attempt to enter the Botox market in the United States as the U.S. Food and Drug Administration (FDA) rejected the documents and data to license the BTX for use, according to industry officials Wednesday.

The company said the FDA recently sent a complete response letter (CRL) for the Letybo BTX product, which is sold under the name Botulax in Korea, as the administration inspected Hugel's production facility and found that it needed to make improvements.

A CRL letter shows the FDA's review of the data submitted by an applicant and indicates that it doesn't approve the application at present. This was the second time that Hugel's attempt to win approval for its BTX product was rejected by the FDA.

Hugel had hoped to bring the BTX product to the U.S. as soon as possible after receiving a favorable review from the FDA, but has now accepted the negative outcome. The company said it will submit a biologics license application (BLA) to win approval.

"When we first applied to the FDA in 2021, we received a CRL letter, and when we reapplied, the FDA conducted a due diligence inspection of the production facility. This time, the FDA conducted an in-depth inspection and told us that there are areas of improvement needed," a Hugel spokesperson said.

"From the outside looking in, they might ask why we didn't get the approval, but getting FDA approval is not simple. We have a year to perfect the kinks and submit the paperwork to win a positive result after six months," the spokesperson added.

Botulax, a botulinum toxin product of Hugel / Courtesy of Hugel

Hugel is currently engaged in a legal tussle in the U.S. as another local Botox producer, Medytox, filed a lawsuit with the U.S. International Trade Commission (USITC) against the company in March 2022.

Medytox claimed that Hugel is making BTX products by stealing its strains and manufacturing know-how. The final ruling on the lawsuit is expected as early as next year.

When asked if the legal tussle with Medytox played a role in the FDA's decision to give the CRL letter, the spokesperson said this is a separate issue from the lawsuit.

"The FDA approval is literally a license to sell the product in the U.S., while the ITC case is a matter that will be addressed after the product is sold in the U.S.," the official said.

Hugel's BTX products are sold in 43 countries. In 2022, the company also received approvals from authorities in 11 countries in Europe for its BTX product. The company aims to win approvals from 25 more countries in Europe within this year.

To further develop its business, the company appointed Cha Suk-yong as executive chairman and chairman of the board on March 30. Cha is a prominent figure in the cosmetics and healthcare industry here as he led LG Household & Health Care for 18 years from 2005 to 2022.

"Based on Chairman Cha's know-how in the field of aesthetics and experience of expanding into global markets, Hugel plans to accelerate its growth by improving the global strategy for its botulinum toxin, HA filler and cosmetics and strengthening the development of new businesses," the company said.

baekby@koreatimes.co.kr