RelabotulinumtoxinA Update from Galderma
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Galderma related to its pending Biologics License Application (BLA) for RelabotulinumtoxinA for the treatment of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients as well as moderate-to-severe lateral canthal lines associated with orbicularis oculi muscle activity in adult patients.
The CRL points out certain deficiencies isolated to items related to chemistry, manufacturing, and controls (CMC) processes. All other aspects of the BLA, including safety and efficacy related parts, did not solicit deficiencies to be addressed. Galderma has already identified changes to the manufacturing process to address feedback. It will also be seeking further guidance through continued open dialogue with the FDA toward resolution of the relevant issues.
Further update on the regulatory filing strategy of RelabotulinumtoxinA and broader neuromodulator R&D partnership
On September 28, 2023, the International Chamber of Commerce (ICC) issued its award on the arbitration commenced by Galderma in 2021 regarding the regulatory filing strategy for RelabotulinumtoxinA, and as a result, the arbitration is complete. While the award is confidential, the result is that the applications submitted for regulatory review are proceeding according to the initial strategy and Galderma and Ipsen await further feedback from regulators.
Galderma remains responsible for development, regulatory filing and strategy, manufacturing, and commercialization. Interactions with regulatory authorities remain the responsibility of Galderma. Regulatory approval submissions and issued certificates will ultimately be in the name of Ipsen.
The ICC award has no impact on the ongoing European decentralized procedure for the filing of RelabotulinumtoxinA nor on the commercialization of Galderma’s neuromodulator portfolio. Regulatory submissions in other territories are ongoing and remain on track.
Furthermore Ipsen made statements about the purported termination of the Galderma-Ipsen Research and Development (R&D) partnership in a press release dated July 27, 2023,. Galderma contests those statements and remains committed to resolution with Ipsen.