Galderma has announced an update on the regulatory review of its Biologics License Application (BLA) for RelabotulinumtoxinA in the United States, following the receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA). The company stated that the regulatory feedback pertains to observations made during a Pre-License Inspection (PLI) of its manufacturing facility, as well as matters related to analytical method optimisation.

According to Galderma, the FDA did not identify any deficiencies concerning the safety or efficacy components of the BLA. The company clarified that the observations are limited to manufacturing-related processes and analytical methods, and it is implementing corrective and preventive actions to address the issues highlighted during the inspection.

Galderma said it will continue to engage in close dialogue with the US FDA to resolve the observations and intends to submit its response to the Complete Response Letter as quickly as possible. The company reaffirmed that advancing RelabotulinumtoxinA in the US market remains one of its highest priorities.

The company also confirmed that the FDA's observations have no impact on approvals, product launches, or ongoing regulatory reviews in international markets.

Marketed as Relfydess, the product has already received regulatory approval in 33 countries and has been commercially launched in more than 20 markets, including Europe, the United Kingdom, the Middle East, Asia and Australia. Galderma said the product has witnessed an encouraging early commercial rollout, supported by positive feedback from healthcare professionals.

Since 2022, the manufacturing facility associated with Relfydess has completed 10 inspections conducted by major global regulatory authorities, providing the foundation for approvals and launches in multiple international markets. The company added that regulatory filings in other territories continue to progress according to plan.

Galderma reiterated its position as a global leader in dermatology across injectable aesthetics, dermatological skincare and therapeutic dermatology. The company highlighted that its integrated capabilities spanning research, development, manufacturing and commercialisation continue to support innovation across its product portfolio.

The company also emphasised the strength of its injectable aesthetics pipeline, noting that it currently has one of the industry's largest portfolios of active aesthetic development programmes. Galderma believes this positions it well to capitalise on the continued growth of the global aesthetics market.

Relfydess is the first ready-to-use liquid neuromodulator developed using Galderma's proprietary PEARL Technology, which is designed to preserve molecule integrity without the need for reconstitution. According to the company, clinical data indicate that up to 39 percent of patients experienced visible effects from the first day of treatment, while up to 75 percent maintained improvements for up to six months. The product is also designed for simplified volumetric dosing to improve ease of use and dosing consistency.

With operations spanning approximately 90 countries, Galderma continues to expand its science-driven portfolio of injectable aesthetics, skincare and therapeutic dermatology products as it pursues its ambition of becoming the world's leading pure-play dermatology company.