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US FDA approves Sanofi's wearable injector form of blood cancer drug

Created at 10 Jul · 1:00 PM1 source↑ Market-relevant
IN SHORT

The U.S. Food and Drug Administration has approved a wearable injector form of Sanofi's multiple myeloma drug, Sarclisa. This subcutaneous delivery offers patients a less burdensome alternative to intravenous infusions.

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Key Numbers

2020year of initial FDA approval for intravenous Sarclisa

Who's Involved

Sanofi
French drugmaker whose blood cancer drug received FDA approval
U.S. Food and Drug Administration
U.S. regulatory agency that approved the drug
Belén Garijo
CEO of Sanofi seeking to strengthen its pipeline
Paulo Fontoura
New R&D head named at Sanofi
US FDA approves Sanofi's wearable injector form of blood cancer drug

↳ Why This Matters

The approval offers a more convenient treatment option for multiple myeloma patients and strengthens Sanofi's drug portfolio, potentially reducing reliance on its top-selling asthma medication.

Key facts

  • The U.S. FDA approved Sanofi's Sarclisa in a wearable injector form.
  • The drug is for patients with multiple myeloma, a rare blood cancer.
  • The wearable injector allows for subcutaneous delivery, reducing infusion center time.
  • The intravenous form of Sarclisa was first approved in 2020.

The U.S. Food and Drug Administration has approved a wearable injector form of Sanofi's blood cancer drug, Sarclisa, providing an alternative to intravenous infusions for patients with multiple myeloma. The new formulation, Sarclisa Escena, utilizes an on-body injector device for subcutaneous delivery.

This approval represents a regulatory win for the French drugmaker as it aims to bolster its drug pipeline. The subcutaneous dosing is expected to reduce the time patients spend at infusion centers and ease the burden on oncology clinics and nursing staff. The intravenous version of Sarclisa initially received FDA approval in 2020 for patients with relapsed multiple myeloma.

Frequently asked questions

Sarclisa is used to treat multiple myeloma, a rare blood cancer that affects plasma cells in the bone marrow.

The new form is called Sarclisa Escena.

It is administered through an on-body injector, a wearable device attached to the skin, for subcutaneous delivery.

The intravenous form of Sarclisa first received FDA approval in 2020.

What Happens Next

01Sanofi will market the new wearable injector form of Sarclisa.

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Cadence

How It Developed

The U.S. FDA approved a wearable injector form of Sanofi's blood cancer drug, Sarclisa.
The drug is now approved for subcutaneous delivery via a wearable injector.
The approval offers multiple myeloma patients an alternative to intravenous infusions.

Sources

T1
US FDA approves Sanofi's wearable injector form of blood cancer drugReuters

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