FDA delays decision on Sanofi's subcutaneous Sarclisa

 The FDA has extended its review of a new subcutaneous formulation of Sanofi's multiple myeloma therapy Sarclisa – which has long played second fiddle to Johnson & Johnson's blockbuster rival Darzalex – by three months.

The US regulator was due to deliver a verdict shortly, but has now set an action date of 23rd July for its review of the new on-body injector (OBI) formulation of the anti-CD38 antibody, which is currently delivered by intravenous infusion.

Sarclisa (isatuximab) has been approved in the US since 2020, initially for relapsed/refractory multiple myeloma before moving into the frontline setting in 2024, and saw sales grow 28% to €588 million ($690 million) last year.

That is eclipsed by Darzalex (daratumumab), however, which made almost $4 billion in the first quarter of this year alone, and is available in both IV and subcutaneous (Darzalex Faspro) formulations.

The OBI version of Sarclisa could go some way to narrowing the canyon between the two drugs, and Sanofi has filed for approval of the new version across all of the drug's current indications.

The company did not give any explanation for the decision to extend the review, merely saying it is "committed to working closely with the FDA to bring this new advancement to patients and providers as quickly as possible."

The Sarclisa OBI – which uses a device developed by Enable Injections that can deliver high volumes of liquid therapies subcutaneously using a hidden, retractable needle – has already been recommended for approval in the EU across all the IV version's indications, with a final decision due in the coming months.

Data presented at last year's ASCO cancer congress showed that Sarclisa OBI was as effective as the current IV formulation when used as a second-line therapy for multiple myeloma, with a reduced treatment time and equivalent safety.

Tzield label widened

Sanofi announced better news from the FDA this morning with the approval of Tzield (tislelizumab), its first-in-class anti-CD3 antibody for delaying the progression of type 1 diabetes (T1D), in children as young as one. It was previously indicated only for patients aged eight and over.

The broader label has been approved on the strength of the PETITE-T1D phase 4 study, which showed young children with stage 2 T1D who were treated with the drug were less likely to progress to stage 3, where clinical symptoms like excessive thirst, frequent urination, weight loss, and fatigue start to occur.

Sanofi acquired Tzield when it bought Provention Bio for $2.9 billion in 2023. Sales of the drug in the US have been slow to take off, but grew 22% to €63 million last year, with a recent approval in Europe (as Teizield) expected to inject some additional momentum. Analysts have suggested that, in time, it could become a $1 billion-a-year brand, with approval in younger children the key to achieving that commercial potential.

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