EU Clears Sanofi’s Sarclisa for Subcutaneous Use With Portable Injector

Overview

• The European Commission approved Sanofi’s Sarclisa in a subcutaneous formulation delivered via a portable injector, a company announcement says.
• Sanofi markets this as the first anticancer therapy in the EU designed for portable, manual subcutaneous injection to be given in outpatient settings or at home.
• The drug was first launched in 2020 and is already authorized in nearly 60 countries and prescribed to about 70,000 patients worldwide.
• Sanofi says the same formulation is under review by regulators in the United States, Japan and China, and earlier this year the U.S. regulator postponed its decision on the subcutaneous version.
• Clinicians and the company say the new option could reduce pressure on infusion centres and increase convenience for patients, but uptake will depend on remaining approvals, reimbursement and local rollout plans.