Galderma’s Relfydess Faces Second FDA Rejection: A Blow to Botox’s Potential Rival
Swiss dermatology leader, Galderma, has experienced another significant setback in its efforts to introduce its innovative anti-wrinkle injectable, Relfydess (relabotulinumtoxinA), to the profitable US market. The US Food and Drug Administration (FDA) issued a complete response letter after a pre-license inspection, leading to a sharp fall in Galderma’s share price — its worst single-day decline in over a year.
Distinct from AbbVie’s blockbuster Botox, Relfydess offers several advantages: it’s ready-to-use (no reconstitution needed before injection) and its effects are considerably longer lasting. The product has already received approval and is commercially available in over 20 countries, including Europe, the United Kingdom, Australia, and parts of Asia. This makes the recurrent US regulatory obstacles even more exasperating for Galderma.
Relfydess’s struggles with the FDA are not new. In 2023, the agency initially rejected the product due to deficiencies in chemistry, manufacturing, and control processes. Galderma asserts that the extent of the recent issues has been “significantly narrowed,” and the company is currently implementing corrective and preventive measures. Barclays analyst James Gordon pointed out that complete response letters have become “the norm” for new neuromodulator approvals in the US, providing some comfort to investors that Relfydess’s journey in America is far from over.
The delay is a setback for Galderma as it strives to compete in the rapidly expanding global aesthetics market, where botulinum toxin products are among the most in-demand treatments worldwide.
Source: Bloomberg — Galderma Shares Slump After FDA Turns Down Botox Rival Relfydess