Biopharmaceutical company Hugel America and aesthetic manufacturer Croma-Pharma has unveiled that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for letibotulinumtoxinA as a treatment for glabellar lines.
The FDA set a Prescription Drug User Fee Act (PDUFA) action date of March 31, 2022, for letibotulinumtoxinA as a neurotoxin to treat moderate-to-severe glabellar lines in adult patients. The BLA accepted the review on June 15 2021.
Consultant plastic, reconstructive and aesthetic surgeon and Aesthetics clinical advisory board lead Mr Dalvi Humzah commented, “As practitioners this development means there more choice available and it will be interesting to see how the different companies will present the data on these drugs and how the market shares of the products evolve with time. Many of these neurotoxins are already available abroad and have been used extensively – how they will be taken up in the UK remains to be seen.”
James Hartman, president of Hugel America, stated, “The FDA’s acceptance of our BLA is an important milestone for Hugel, as it brings us one step closer to our goal of becoming a top aesthetics brand in the US by delivering high quality solutions that are accessible and attainable. We believe the market can continue to evolve and we look forward to participating in that evolution.”
Currently, letibotulinumtoxinA is available in 28 countries. According to Hugel, they are hoping to soon expand into Canada, Australia and New Zealand.