Galderma Application for Product to Rival Botox Turned Down Again by FDA

Galderma's liquid neurotoxin, RelabotulinumtoxinA (marketed as Relfydess™), designed to optimize molecule integrity for fast onset and sustained results for frown lines and crow's feet, was initially rejected by the FDA in October 2023 due to chemistry, manufacturing, and controls (CMC) issues. The initial rejection focused specifically on manufacturing process issues. This neurotoxin is intended to compete with existing treatments like Botox.

Following the initial rejection, Galderma worked closely with the FDA to implement adjustments to its manufacturing process. The company subsequently resubmitted its Biologics License Application (BLA) for RelabotulinumtoxinA, which the FDA accepted for review. The resubmission aimed to address the previously identified CMC concerns and pave the way for U.S. approval.

RelabotulinumtoxinA has already received marketing authorization in over 20 markets globally, including the European Union, the United Kingdom, Asia, and Australia, where it is approved for the temporary improvement of moderate-to-severe glabellar lines and lateral canthal lines. Clinical trials, part of the READY (Relabotulinumtoxin Aesthetic Development Study) program involving over 1,900 participants, demonstrated a fast onset of action as early as Day 1 and sustained results for six months for both frown lines and crow's feet. The product is also unique as the first and only ready-to-use liquid neuromodulator manufactured with PEARL™ Technology, eliminating the need for reconstitution.

While the FDA accepted the BLA resubmission, the initial rejection highlighted the stringent regulatory environment in the U.S. for new aesthetic treatments. The current status indicates that while an initial application was rejected, the company has since resubmitted, and the FDA has accepted this resubmission, putting the product back in active review for potential U.S. market entry. The timeline for approval will depend on the FDA's classification of the resubmission, which could be either a two-month or six-month review period.