Sanofi's Subcutaneous Sarclisa Approved in EU Across Multiple Myeloma Indications

MT Newswires Live06-08

Sanofi's (SNY) Sarclisa received European Commission's approval for its subcutaneous formulation across all European Union indications currently authorized for the intravenous treatment in multiple myeloma, the company said Monday.

With the approval, Sarclisa becomes the first anticancer medicine in the EU available through an on-body injector, enabling treatment in outpatient clinics and patients' homes.

The decision was supported by phase 3 IRAKLIA data showing that subcutaneous Sarclisa delivered via an on-body injector was non-inferior to the intravenous version in patients with relapsed or refractory multiple myeloma, Sanofi said.

The company added that subcutaneous Sarclisa was associated with fewer systemic infusion reactions than the intravenous form, with no new safety concerns beyond mostly low-grade injection-site reactions.

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