FDA issues complete response letter to Galderma for RelabotulinumtoxinA

The FDA issued a Complete Response Letter to Galderma regarding its Biologics License Application for RelabotulinumtoxinA (QM-1114), delaying the potential entry of this liquid neuromodulator into the US market. The regulator cited deficiencies isolated strictly to chemistry, manufacturing, and controls processes, meaning there are no outstanding safety or efficacy concerns for the product.

This delay pauses a promising clinical profile. Across four phase 3 clinical trials involving more than 1,900 participants, the ready-to-use liquid formulation showed rapid onset, with 39% of patients seeing results on day one for frown lines and 34% seeing results on day one for crow's feet.

The regulatory path is also shaped by a completed International Chamber of Commerce arbitration from a dispute commenced in 2021 between Galderma and Ipsen. While Galderma remains responsible for the development, regulatory strategy, manufacturing, and commercialization of the drug, the final regulatory approvals will ultimately be held in Ipsen's name. For your clinic, this means keeping your current neuromodulator rotation intact for now, as Galderma must first resolve the manufacturing issues with the FDA before a commercial launch date can be established.

Source: The Aesthetic Guide, https://www.theaestheticguide.com/view/galderma-provides-update-on-relabotulinumtoxina