On April 22, 2026, the FDA extended the review timeline for Sanofi's biologics license application for subcutaneous Sarclisa (isatuximab-irfc), pushing the target action date from April 23, 2026, to July 23, 2026.1
The delay is to scrutinize the on-body injector delivery system as a combination product, despite positive phase 3 IRAKLIA data showing pharmacokinetic equivalence to the intravenous formulation.1
Prediction markets reflect 97.9% consensus against approval by the original PDUFA date of April 23, 2026, with resolution by May 7, 2026.1
Subcutaneous Sarclisa is intended for relapsed/refractory multiple myeloma.1
Sources:
1. https://polymarket.com/event/fda-approves-sanofis-sarclisa