Galderma received a Complete Response Letter from the FDA with comments related to observations during manufacturing site inspection and analytical method optimization Relfydess is approved in 33 markets and already launched in more than 20, including across Europe, the Middle East and Australia, with an encouraging early launch trajectory supported by positive healthcare professional feedback Regulatory filings in other territories are ongoing and remain on track Ad hoc announcement pursuant to Art. 53 LR ZUG, Switzerland — Galderma (SIX: GALD) today provided progress updates regarding
the regulatory review of its pending Biologics License Application (“BLA”) for RelabotulinumtoxinA with the U.S. Food and Drug Administration (“FDA”). The Company has received a Complete Response Letter (CRL) from the FDA with comments related to observations during manufacturing site inspection and analytical method optimization. As part of its review, the FDA conducted a Pre-License Inspection (PLI) of Galderma’s manufacturing site. All other aspects of the BLA, including safety- and efficacy-related parts, did not solicit deficiencies to be addressed. The FDA made observations during the
PLI for which Galderma is putting in place corrective and preventive actions. Galderma will also be seeking further guidance through continued open dialogue with the FDA toward resolution of the relevant observations. Galderma plans to rapidly respond to the CRL and advancing RelabotulinumtoxinA in the U.S. remains a top priority. The observations do not impact approvals, launches, or regulatory reviews in other International markets. Global launches progressing on track As of today, Relfydess is approved in 33 markets and already launched in more than 20,
including in Europe, the United Kingdom, the Middle East, Asia, and Australia, with an encouraging early launch trajectory supported by positive healthcare professional feedback. Since 2022, this Galderma manufacturing site has completed 10 inspections from key regulatory authorities from around the world serving as the basis for International Relfydess launches. Regulatory filings in other territories are ongoing and remain on track. Building a dermatology powerhouse Galderma remains on a clear path to become the world’s undisputed dermatology powerhouse spanning the full spectrum of fast-growing markets
across Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. In Injectable Aesthetics, Galderma is firmly positioned on a trajectory to global leadership – not only in sales and market share, but also in innovation – supported by fully integrated in-house capabilities across discovery, research, development, manufacturing and commercialization of best-in-class products. We will continue to build on this momentum through our robust pipeline, expanding the number of early-stage assets under development. Galderma leads the industry in the number of active aesthetic development programs, further reinforcing its
leadership position in the U.S. and globally. Galderma has the largest and most innovative Injectable Aesthetic portfolio on the market. Given our strong market position, we believe we are exceptionally well placed to capitalize on opportunities in this fast-growing market. About Relfydess (relabotulinumtoxinA) Pioneered by Galderma, Relfydess is the first and only ready-to-use liquid neuromodulator created with PEARL Technology that is designed to preserve molecule integrity. PEARL Technology is designed to deliver a highly active, innovative, complex-free molecule, creating a product that enables up to
39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months. Relfydess is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time. 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20260630345734/en/ For further information: Christian Marcoux, M.Sc. Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50 Richard Harbinson Corporate Communications Director
richard.harbinson@galderma.com +41 76 210 60 62 Céline Buguet Franchises and R&D Communications Director celine.buguet@galderma.com +41 76 249 90 87 Emil Ivanov Head of Strategy, Investor Relations, and ESG emil.ivanov@galderma.com +41 21 642 78 12 Jessica Cohen Investor Relations and Strategy Director jessica.cohen@galderma.com +41 21 642 76 43
Galderma, FDA, Complete Response Letter, relabotulinumtoxinA, Relfydess, Biologics License Application, manufacturing inspection, analytical method optimization, Pre-License Inspection
So it’s delayed because the FDA inspected? That sounds normal tbh.
If they already approved it in like 33 markets, why are we still acting like the FDA “found something”?? Seems like red tape to me. Or maybe it’s just not safe here, idk.
Complete Response Letter… so does that mean it’s approved but they’re just updating paperwork or what? I’m confused because the article says no safety/efficacy deficiencies, but then it still got a CRL.
Analytical method optimization?? Sounds like they’re tweaking how they test stuff which is basically admitting quality issues. Also relabotulinumtoxinA sounds like Botox, so if other places have it why not here immediately. This is probably gonna keep getting pushed while they “seek further guidance.”