Galderma, a rising star in the dermatology sector, has provided an update on the regulatory front regarding its pending Biologics License Application (BLA) for RelabotulinumtoxinA (QM-1114) submitted to the U.S. Food and Drug Administration (FDA).
The FDA has issued what’s known as a Complete Response Letter (CRL) to Galderma in relation to its BLA for RelabotulinumtoxinA. This application pertains to the treatment of moderate-to-severe glabellar lines (frown lines) linked to the activity of the corrugator and/or procerus muscles in adult patients. It also covers the treatment of moderate-to-severe lateral canthal lines (crow’s feet) associated with the orbicularis oculi muscle activity in adult patients.
The CRL specifically highlights certain deficiencies in the Chemistry, Manufacturing, and Controls (CMC) processes of the application. Importantly, all other facets of the BLA, including safety and efficacy-related components, have not raised any deficiencies that need to be addressed.
Galderma has proactively identified necessary changes to its manufacturing processes to rectify the issues pinpointed in the CRL. The company is committed to engaging in continued open dialogue with the FDA, seeking their guidance to ensure the resolution of these pertinent matters.
While this represents a temporary setback, Galderma’s dedication to resolving the CMC-related issues underscores its commitment to delivering safe and effective treatments to patients seeking relief from glabellar lines and crow’s feet. The journey toward regulatory approval continues, with the aim of bringing innovative dermatological solutions to those in need.
Further update on the regulatory filing strategy of RelabotulinumtoxinA and broader neuromodulator R&D partnership
In a recent development, on September 28, 2023, the International Chamber of Commerce (ICC) issued its award pertaining to the arbitration initiated by Galderma back in 2021. This arbitration centered around the regulatory filing strategy for RelabotulinumtoxinA.
The arbitration process is now concluded, and while the specific details of the award remain confidential, the outcome signifies that the applications submitted for regulatory review are proceeding in alignment with the original strategy. Galderma and Ipsen are eagerly awaiting further input and guidance from regulatory authorities.
Galderma retains its responsibilities in various critical areas, including development, regulatory filing and strategy, manufacturing, and commercialization. The interactions with regulatory agencies continue to fall within Galderma’s purview. Ultimately, regulatory approval submissions and issued certificates will carry Ipsen’s name.
Importantly, the ICC award does not exert any influence on the ongoing European decentralized procedure for the RelabotulinumtoxinA filing or the commercialization of Galderma’s neuromodulator portfolio. Regulatory submissions in other regions are progressing as planned and remain on track.
Furthermore, in a press release dated July 27, 2023, Ipsen made statements regarding the alleged termination of the Galderma-Ipsen Research and Development (R&D) partnership. Galderma disputes these statements and is actively working toward a resolution with Ipsen.
Through all of this, Galderma remains unwavering in its commitment to advancing scientific innovation for healthcare professionals, consumers, and patients across the globe. The expansion of its neuromodulator portfolio stands as a testament to its dedication, further solidifying its position as a leader in the Injectable Aesthetics arena.
Galderma stands at the forefront of the dermatology field as a leading player, operating in around 90 countries. We are committed to delivering a range of innovative, science-driven products and services that encompass the entire spectrum of the rapidly growing dermatology market. Our expertise extends across Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology.
Since our inception in 1981, our unwavering focus and passion have revolved around the skin, the body’s largest organ. We are dedicated to meeting the unique needs of individual consumers and patients, collaborating closely with healthcare professionals to achieve superior outcomes. We recognize that the skin we inhabit plays a pivotal role in shaping our lives, and we are dedicated to advancing the field of dermatology for every skin story.
Galderma boasts a portfolio of flagship brands, including Restylane®, Dysport®, Azzalure®, Alluzience®, and Sculptra® in the realm of Injectable Aesthetics. In the domain of Therapeutic Dermatology, we offer a comprehensive lineup that includes Soolantra®, Epiduo®, Differin®, Aklief®, Epsolay®, Twyneo®, Oracea®, Metvix®, Benzac®, and Loceryl®. Our commitment to Dermatological Skincare is embodied by renowned brands such as Cetaphil® and Alastin Skincare®.
With a deep understanding of the profound impact that our skin has on our lives, Galderma is dedicated to advancing the field of dermatology, ensuring that every skin story finds the solutions and support it deserves.