What's Happening?
The FDA has postponed its decision on Sanofi's new subcutaneous formulation of Sarclisa, a therapy for multiple myeloma, by three months. Originally expected to deliver a verdict soon, the FDA has now set a new action date for July 23. Sarclisa, an anti-CD38
antibody, is currently administered intravenously and has been approved in the U.S. since 2020. The new on-body injector (OBI) version aims to offer a more convenient administration method. Despite Sarclisa's sales growth, it remains overshadowed by Johnson & Johnson's Darzalex, which is available in both intravenous and subcutaneous forms. Sanofi has not provided a reason for the review extension but expressed commitment to working with the FDA to expedite the process. The OBI version has already been recommended for approval in the EU.
Why It's Important?
The delay in the FDA's decision on Sarclisa's subcutaneous version is significant for Sanofi as it seeks to enhance its competitive position against Darzalex, a leading therapy in the multiple myeloma market. The new formulation could potentially increase patient convenience and adherence, thereby boosting Sarclisa's market share. The decision also impacts healthcare providers and patients who may benefit from a less invasive treatment option. For Sanofi, the approval of the OBI version is crucial to closing the sales gap with Darzalex and achieving broader market penetration.
What's Next?
Sanofi will continue to collaborate with the FDA to address any outstanding issues and facilitate the approval process. The company is likely to focus on demonstrating the efficacy and safety of the OBI version to ensure a favorable decision. Meanwhile, the EU's pending approval could provide a boost to Sarclisa's market presence in Europe. Stakeholders, including healthcare providers and patients, will be closely monitoring the FDA's decision, as it could influence treatment protocols and options for multiple myeloma.
