FDA Turns Down Galderma’s Botox Competitor Relfydess for the Second Time
Swiss dermatology titan Galderma encountered a significant hurdle this week when the U.S. Food and Drug Administration (FDA) delivered a Complete Response Letter (CRL). This letter rejected Galderma’s eagerly awaited Botox competitor, Relfydess (relabotulinumtoxinA). This marks the second FDA rejection in a span of three years.
Following this announcement, Galderma’s shares plummeted to their lowest level in over a year. The FDA’s observations during a pre-license manufacturing site inspection led Galderma to initiate corrective and preventive measures. Unlike AbbVie’s Botox, which requires reconstitution before injection, Relfydess is a ready-to-use liquid neuromodulator. It also claims to provide longer-lasting results, making it one of the most closely monitored products in aesthetic medicine.
Despite the setback in the U.S., Relfydess has already received approval in 33 international markets, including Europe, the UK, Australia, and parts of Asia. Galderma has assured that the FDA’s observations will not impact these existing approvals or ongoing global regulatory reviews. Jefferies’ analysts predict a 9–12 month delay in U.S. approval but view any share price drop as a buying opportunity, attributing it to a “temporary softening” of growth. Galderma has expressed its commitment to promptly respond to the CRL and to continue its efforts to introduce Relfydess to American patients.
Source: The Dermatology Digest — Galderma Receives US FDA Complete Response Letter for RelabotulinumtoxinA