After SC, Now Wearables: First FDA Approval for On-Body Injectable Anticancer Drug in the US

Sanofi's Subcutaneous Multiple Myeloma Therapy Approved in U.S.

Anticancer Drug Automatically Administered After Abdominal Attachment

A device that automatically injects anticancer drugs when attached to the body has been approved for the first time in the United States. The method of administering anticancer drugs is expanding from intravenous (IV) administration to subcutaneous (SC) injections, and now to wearable devices.

According to the industry on July 14, the U.S. Food and Drug Administration (FDA) approved Sanofi's multiple myeloma treatment "Sarclisa Essena" subcutaneous injection On-Body Injector (OBI) on July 9 (local time). The system uses an on-body injector called "CirCLIQ," which attaches to the abdomen and automatically delivers the drug subcutaneously. According to Sanofi, this is the first time the FDA has approved administering an anticancer drug using an on-body injector.

The hands-free OBI of Enable Injection, approved along with Sanofi's multiple myeloma treatment Salclusa. Enable Injection

An on-body injector is a medical device that contains medication inside a small unit, which is attached to the skin and automatically injects the drug over a set period of time. When CirCLIQ is attached to the abdomen and a button is pressed, a needle inside the device enters the area beneath the skin to deliver the drug. Once the injection is complete, the needle retracts back into the device. This "hands-free" method eliminates the need for medical staff to continuously push a syringe until all the medication has been administered.

Sarclisa delivers 1,400 mg of isatuximab subcutaneously regardless of the patient's weight. It takes about 13 minutes for administration via the on-body injector. In comparison, the existing intravenous (IV) formulation of Sarclisa takes over three hours for the first dose, so this method significantly reduces the hospital stay for patients who require repeated administrations.

With conventional subcutaneous injections of anticancer drugs, medical staff must directly administer the medication even if the injection time is short. With the on-body injector, once the device is attached, the drug is automatically injected, allowing medical staff to monitor the patient or attend to other work. The company believes that outpatient infusion rooms where anticancer drugs are administered repeatedly will be able to use limited staff and space more efficiently through this approach.

The European Union (EU) actually approved the Sarclisa subcutaneous injection and on-body injector format last month, ahead of the United States. In the EU, medical staff are permitted to administer the drug not only in outpatient clinics, but also at patients' homes. In contrast, the U.S. has approved the device only for use in hospitals. It is expected to take some more time for introduction in South Korea. Although the original intravenous version of Sarclisa was approved by the Ministry of Food and Drug Safety in 2020, it has not yet been launched domestically due to reimbursement and other issues.

The industry expects that on-body injectors will expand their applicability, particularly for antibody therapies and other biopharmaceuticals that require repeated dosing. Patients will benefit from reduced hospital stays, while medical institutions will be able to treat more patients with limited staff. However, challenges remain, such as the cost of disposable devices and the need for proper management of the medical devices themselves.

In South Korea, Alteogen is collaborating with U.S. medical device company Becton Dickinson (BD) to combine its recombinant hyaluronidase "ALT-B4" with BD's 10 mL wearable injector "Libertas." In May, the two companies released preclinical results in a pig model, evaluating injection time for high-volume drugs and tissue spread within the subcutaneous layer.

This content was produced with the assistance of AI translation services.