Galderma Announces U.S. FDA Acceptance of RelabotulinumtoxinA Biologics License Application Resubmission

• The United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) resubmission for RelabotulinumtoxinA for the temporary improvement of moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults
• RelabotulinumtoxinA is designed to optimize molecule integrity to deliver fast onset of action as early as Day 1 and sustained results for six months for frown lines and crow’s feet and has been approved in over 20 markets, including in the European Union^1-3

ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SIX: GALD) today announced that the U.S. FDA has accepted the BLA resubmission for RelabotulinumtoxinA for the temporary improvement of moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults. Galderma has worked closely with the U.S. FDA to implement adjustments to its manufacturing process. Galderma is committed to using its expertise and heritage in the neuromodulator space to develop next-generation aesthetic solutions that address evolving needs.

“We pioneered the development of RelabotulinumtoxinA to address the growing demand for faster-acting and longer-lasting anti-wrinkle solutions. We’re excited about the potential to bring this innovative neuromodulator to the U.S., offering advanced performance and ease of use and building on our portfolio of neuromodulators that meets the full spectrum of injector and patient needs.”   BALDO SCASSELLATI SFORZOLINI, M.D., PH.D. GLOBAL HEAD OF R&D GALDERMA

The filing is based on data from the robust, large-scale READY (REelabotulinumtoxin Aesthetic Development StudY) clinical trial program, which is composed of four phase III trials, enrolling more than 1,900 participants.^1-4 Results demonstrated that RelabotulinumtoxinA delivered a fast onset of action as early as Day 1 and sustained results for six months for both frown lines and crow’s feet.^1,2

RelabotulinumtoxinA (Relfydess™) has been approved in over 20 markets for the treatment of frown lines and crow’s feet, including in the European Union, the United Kingdom, Asia, and Australia. Regulatory applications are continuing to be submitted and assessed by additional authorities globally.

Galderma offers a range of neuromodulator solutions aiming to address every single injector and patient need, and has the heritage, expertise and capability needed to continue bringing this advanced solution to patients and healthcare professionals globally. Today, Galderma is well positioned to be the leader in all aspects of Injectable Aesthetics, having the in-house capabilities to discover, research, develop, manufacture, and market best-in-class products.

About RelabotulinumtoxinA

Pioneered by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator manufactured with PEARL™ Technology, which is designed to preserve molecule integrity to deliver fast onset of action as early as Day 1 and sustained results for six months for glabellar lines and lateral canthal lines, giving patients a natural, revitalized look in a refined and well-tolerated formulation.^1-5 RelabotulinumtoxinA is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.^6,7 It was entirely created and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market. RelabotulinumtoxinA has received a marketing authorization in numerous markets and is an investigational drug product in the U.S. Authorization conditions may vary internationally.

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References

1. Shridharani SM, et al. Efficacy and safety of RelabotulinumtoxinA, a new ready-to-use liquid formulation botulinum toxin: Results from the READY-1 double-blind, randomized, placebo-controlled phase 3 trial in glabellar lines. Aesthet Surg J. 2024;44(12):1330-1340. doi: 10.1093/asj/sjae131.
2. Ablon G, et al. Treatment of lateral canthal lines with RelabotulinumtoxinA, an investigational liquid botulinum toxin: clinical efficacy and safety results from the READY-2 phase 3 trial. Toxicon. 2024;237(1):107353. doi: 10.1026/j.toxicon.2024.107353.
3. Relfydess^®. EU Summary of Product Characteristics.
4. Galderma. Data on file. Clinical Study Report for Protocol 43QM1902: READY-3. Galderma Laboratories; 2021
5. Galderma. Data on file. Clinical Study Report for Protocol 43AM1903: READY-4. Galderma Laboratories; 2021
6. Sundberg AL and Stahl U. Relabotulinum toxin - a novel, high purity BoNT-A1 in liquid formulation. Presented at TOXINS; January 16-17, 2021; virtual meeting.
7. Do M, et al. Purification process of a complex-free highly purified botulinum neurotoxin type A1 (BoNT-A1) - relabotulinumtoxinA. Presented at TOXINS; July 27-30, 2022; Louisiana, United States.