Galderma has announced that the United States Food and Drug Administration (FDA) has accepted the resubmission of its Biologics License Application (BLA) for RelabotulinumtoxinA.
The application seeks approval for the temporary improvement of moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults.
The company stated that it worked closely with the FDA to implement adjustments to its manufacturing process prior to the resubmission. RelabotulinumtoxinA is designed to optimise molecule integrity, enabling a fast onset of action as early as Day 1 and sustained results lasting up to six months for both frown lines and crow’s feet.
The BLA filing is supported by data from the READY (REelabotulinumtoxin Aesthetic Development StudY) clinical trial programme, which includes four phase III studies and enrolled more than 1,900 participants. Results from these trials demonstrated rapid onset of effect and durability of results for up to six months in the targeted indications.
RelabotulinumtoxinA, marketed as Relfydess™, has already received regulatory approval in more than 20 markets worldwide, including the European Union, the United Kingdom, parts of Asia and Australia. Additional regulatory submissions are ongoing and under review in other regions globally. In the United States, the product remains an investigational drug.
Galderma highlighted that RelabotulinumtoxinA is the first ready-to-use liquid neuromodulator manufactured using its proprietary PEARL™ Technology, which is designed to preserve molecule integrity. The product is formulated for simple volumetric dosing without the need for reconstitution, aiming to improve ease of use and ensure consistent dosing. It was entirely developed and manufactured by Galderma as part of its broader injectable aesthetics portfolio.
The company stated that it continues to leverage its expertise in neuromodulators and injectable aesthetics to develop next-generation solutions addressing evolving needs of healthcare professionals and patients, positioning itself to support discovery, development, manufacturing and global commercialisation of aesthetic products.
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