Galderma says FDA rejected U.S. application for Relfydess antiwrinkle injection

Galderma said the U.S. Food and Drug Administration declined its application for Relfydess, a botulinum-toxin injection marketed internationally as relabotulinumtoxinA, after raising concerns tied to a manufacturing-site inspection and the company’s analytical method.

The rejection is the latest setback for Galderma’s effort to bring a Botox rival to the U.S. market. It is also the second time in three years that the FDA has turned down the company’s filing for the product, according to the report.

Galderma said the complete response letter did not raise safety or efficacy deficiencies, and that it is implementing corrective and preventive actions while continuing to pursue U.S. approval.

What the FDA said

According to Galderma’s statement as reported by the Wall Street Journal, the agency cited observations from a manufacturing-site inspection and comments about the analytical method used in the submission.

Those issues can delay a filing even when the agency is not questioning the drug’s core clinical profile. Galderma said the product had no deficiencies on safety or efficacy, based on its account of the letter.

Why it matters

Relfydess is one of Galderma’s key aesthetic products and a potential competitor to AbbVie’s Botox. A U.S. launch would give the company another chance to compete in the large wrinkle-treatment market.

Galderma already sells injectable aesthetics products in some markets, and executives cited by WSJ said Relfydess is approved in countries including Germany and Spain.

The setback could push back revenue tied to a planned U.S. launch and weigh on investor sentiment. WSJ reported that Galderma shares fell as much as 6.9% after the news.

Next steps

Galderma said it remains committed to U.S. approval and is working through corrective actions. The next key milestone will be the company’s response to the FDA letter and any timetable for resubmission.

Investors will also be watching for management guidance on how long the remediation process may take and whether the delay affects the company’s broader launch plans.