The U.S. Food and Drug Administration (FDA) on Wednesday delayed its decision on Sanofi SA’s (NASDAQ:SNY) subcutaneous Sarclisa formulation while separately broadening the eligible patient population for Tzield.
FDA Extends Sarclisa SC Review Timeline
The FDA has pushed its target action date for the biologics license application for Sarclisa (isatuximab-irfc) subcutaneous (SC) formulation by up to three months.
The agency now expects to deliver its decision by July 23.
The application covers the use of Sarclisa SC in combination with standard-of-care regimens for patients with multiple myeloma across all currently approved U.S. indications of the intravenous version.
If cleared, the subcutaneous version could become the first anticancer treatment delivered via an on-body injector, offering a potentially more convenient administration method.
Positive Momentum In Europe
In March, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of Sarclisa SC.
The recommendation includes both on-body injector and manual injection methods for treating multiple myeloma across all approved indications tied to the intravenous formulation.
European authorities are expected to make a final decision in the coming months.
Nearly 60 countries have already approved Sarclisa across four indications, and more than 60,000 patients globally have used it.
FDA Expands Tzield Use In Younger Patients
In a separate decision on Wednesday, the FDA approved a supplemental biologics license application for Tzield (teplizumab-mzwv), expanding its use to children as young as one year old.
The therapy aims to delay the onset of stage 3 type 1 diabetes in patients diagnosed with stage 2 disease. Regulators previously approved it for patients aged eight years and older.
The agency granted the approval under priority review and backed it with data from the PETITE-T1D phase 4 study, which evaluated safety and pharmacokinetics in younger children.
Tzield remains the first disease-modifying therapy indicated for delaying disease progression in early-stage type 1 diabetes and is also under FDA review for an additional use in newly diagnosed stage 3 patients aged eight and older.
SNY Stock Price Activity: Sanofi shares were up 0.87% at $47.54 during premarket trading on Wednesday, according to Benzinga Pro data.
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