FDA starts reviewing Hugel’s biologics license application for BTX

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Hugel said the U.S. Food and Drug Administration (FDA) started reviewing its biologics license application (BLA) for Letybo (brand name in Korea: Botulax), its botulinum toxin (BTX) formulation, to treat forehead wrinkles on Tuesday.


The FDA has started reviewing Hugel's BLA for Letybo
The FDA has started reviewing Hugel’s BLA for Letybo


This is the second time that Hugel filed a BLA for Letybo to the FDA.


The company had previously submitted a BLA regarding Letybo to the FDA in June of last year. However, the U.S. drug agency sent out a CRL (Complete Response Letter) requesting that the company supplement chemistry manufacturing and controls (CMC) issues.


Hugel has since completed the data supplementation in accordance with the CRL and resubmitted the application to the FDA on Oct. 7.


According to Hugel, the FDA will conduct the BLA review for six months in accordance with the Prescription Drug User Fee Act (PDUFA),. Hugel hopes to get the FDA decision by April 6, 2023.


“The company is focusing on launching Letybo in the U.S. in the middle of next year,” Hugel America President James Hartman said.


However, even if Hugel receives U.S. approval, industry watchers expect that Hugel will have to fiercely compete to gain a BTX market share for Letybo in the U.S.


Allergan’s Botox has almost monopolized the BTX market until a few years ago and the competition against other rivals is intensifying.


Notably, Daewoong’s Jeuveau (brand name in Korea: Nabota) recorded $99.7 million in sales last year, an increase of more than 76 percent from $56.5 million in 2020. Jeuveau’s 2021 revenue was equivalent to about 7 percent of Botox’s U.S. sales of $1.424 billion, and has become a notable competitor.


Most recently, Revance Therapeutics, a U.S. biotechnology firm, also received FDA approval for Daxxify, a next-generation BTX in formulation, in September.


Also, Hugel has yet to be free from the U.S. International Trade Commission (ITC) probe over a complaint submitted by Medytox.


Medytox had submitted the complaint to the ITC, alleging that Hugel developed Letybo using a stolen manufacturing secret in April.


If ITC makes a ruling  in favor of Medytox, it may order an import ban on Hugel’s products.


Meanwhile, the ITC ruling date has recently been postponed at least until November 2023 as requested from the relevant parties, including Medytox and Hugel. 

The relevant parties had requested the delay due to late approval from the Ministry of Trade, Industry and Energy (MOTIE) regarding the data it needs to submit to the ITC.


Medytox had requested the delay due to late approval from the Ministry of Trade, Industry and Energy (MOTIE) regarding the data it needs to submit to the ITC.


BTX is one of the core state technologies designated by the government, requiring the MOTIE’s approval to take out related data overseas.


Hugel’s shares remained nearly unchanged despite the reapplication news. As of 2:00 p.m., Friday, shares traded at 110,700 won ($78), down 0.27 percent from the previous trading day.



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