Relfydess remains approved in 33 markets

Galderma has received a Complete Response Letter from the US Food and Drug Administration for RelabotulinumtoxinA, delaying the US filing for Relfydess.

The company linked the letter to observations from an FDA pre-licence inspection of a manufacturing site and to analytical method optimisation.

Galderma said: “All other aspects of the BLA, including safety- and efficacy-related parts, did not solicit deficiencies to be addressed.”

The letter means the FDA did not identify new deficiencies in the safety and efficacy sections of the biologics licence application.

As part of the review, the FDA carried out a Pre-Licence Inspection, or PLI, at the company’s manufacturing site.

Following that inspection, the group is putting corrective and preventive actions in place for the agency’s observations. It also plans to continue talks with the FDA to resolve the remaining points.

The company said advancing RelabotulinumtoxinA in the United States remains a top priority and that it plans to respond rapidly to the CRL.

Outside the United States, the product’s rollout is continuing. Relfydess is approved in 33 markets and has already launched in more than 20.

Those launches include Europe, the United Kingdom, the Middle East, Asia and Australia. Galderma said the observations do not affect approvals, launches or regulatory reviews in other international markets.

Early launch performance has been encouraging, with positive feedback from healthcare professionals.

Meanwhile, regulatory filings in other territories are ongoing and remain on track.

10 inspections since 2022

Since 2022, the same manufacturing site has completed 10 inspections by key regulatory authorities from around the world.

According to Galderma, those inspections served as the basis for international Relfydess launches already completed outside the US.

The update was issued from Zug, Switzerland, under an ad hoc announcement pursuant to Article 53 LR.

Galderma trades on SIX under the ticker GALD. The company tied the Relfydess update to its broader dermatology strategy.

That strategy spans Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology.

In aesthetics, the group said it is building on its pipeline by expanding the number of early-stage assets under development.