FDA delays US launch of Galdermas liquid neuromodulator Relfydess

The FDA has rejected Galderma's biologics license application for its ready-to-use liquid neuromodulator Relfydess (relabotulinumtoxinA) for the second time, pushing back the timeline for clinicians looking to add a pre-diluted competitor to Botox and Dysport.

The regulatory setback came via a Complete Response Letter containing FDA comments on an inspection of Galderma's manufacturing facility and analytical method optimization. While this means the treatment is blocked from the US market for now, Galderma is already implementing corrective and preventive actions to address the agency's feedback. Jefferies analysts estimate this delay will push back the US launch timeline by nine to 12 months, though RBC Capital Markets analysts note this is a localized delay rather than a fundamental issue with the drug itself.

For aesthetics practices, this delays a highly anticipated product that was expected to streamline back-bar workflows. Because Relfydess is a liquid formulation, it eliminates the reconstituting step, reducing the risk of calculation errors and preserving active potency. This setback keeps the liquid toxin space largely open for competitors, meaning you will need to rely on standard reconstituted toxins for the foreseeable future. Expect Galderma to resolve these manufacturing issues and resubmit, but adjust your purchasing plans and training schedules to reflect that this product will not be on US shelves for at least another year.

Source: MarketScreener, https://www.marketscreener.com/quote/stock/GALDERMA-GROUP-AG-162137684/news/Galderma-Group-failed-to-secure-approval-from-the-U-S-FDA-for-its-latest-antiwrinkle-treatment-47098471/