Approval is supported by IRAKLIA phase 3 data showing non-inferiority of SC to IV in efficacy and pharmacokinetics, with a favorable safety profile.

In IRAKLIA, most common grade 3+ non-hematologic AEs were pneumonia and COVID-19, while neutropenia, thrombocytopenia, and anemia were the leading hematologic events; infusion reactions were notably reduced with SC.

This marks the second global approval for the SC formulation after the EU, with CirCLIQ on-body injector submission in Japan still under review.

The article notes the piece was AI-assisted and editor-reviewed.

Japan has approved Sarclisa subcutaneous (SC) in combination regimens for relapsed or refractory multiple myeloma and newly diagnosed cases, expanding options beyond intravenous delivery.

The report citing Marketscreener notes the publication date as June 19, 2026.

Other market notes include Santander’s Q1 2026 earnings beat, a $1.5 billion Tier 1 preferred issue, Webster Financial’s takeover proposal approval, and risk-transfer plans for a €500 million BNPL portfolio from Openbank.

IRAKLIA is a randomized, open-label phase 3 trial (NCT05405166) assessing primary outcomes of overall response rate and trough concentration at steady state.

SC administration markedly reduces infusion reactions (about 1.5% vs 25% IV) with minimal local injection-site events (0.4%, mostly grade 1).

Attachments include the Sarclisa press release and links to its clinical trials.

Enable Injections is developing the enFuse On-Body Delivery System to automate SC Sarclisa delivery, aiming to lessen treatment burden and improve convenience.

Sanofi reported positive phase 2 results for efdoralprin alfa in alpha-1 antitrypsin deficiency, indicating increased functional protein levels.