UK will be first market for Sanofi's subcutaneous Sarclisa

 Sanofi's subcutaneous formulation of multiple myeloma drug Sarclisa has been approved in the UK, which will be the first market for the on-body injector (OBI) version of the drug.

The company is hoping that the new Sarclisa (isatuximab) product, which uses the CirCLIQ OBI device, could go some way toward narrowing the massive market share gap between the anti-CD38 antibody and its main rival, Johnson & Johnson and Genmab's Darzalex (daratumumab), which made $14.35 billion in sales last year to Sarclisa's $690 million.

Both Sarclisa and Darzalex are available in intravenous versions, and CirCLIQ OBI is Sanofi's response to subcutaneous Darzalex Faspro, which was approved in 2020. It was also approved in the EU earlier this month, but a decision in the US has been delayed until next month.

The new product is the first anticancer treatment administered via an OBI to be approved for marketing, according to Sanofi, which said it "offers a treatment experience designed around the needs of patients and HCPs and enables flexible administration in either home or outpatient settings."

The OBI device can deliver high volumes of subcutaneous therapies using a hidden, retractable needle, and draws on the enFuse technology developed by Enable Injections, a company first set up in 2022 that is backed financially by private equity group Blackstone Life Sciences. It can deliver doses both manually and at automated intervals.

"Multiple myeloma is a complex disease that often requires repeated and prolonged clinic visits, placing a considerable burden on patients and those who support them," said senior haematologist Karthik Ramasamy of Oxford University Hospital NHS Trust and the Oxford Translational Myeloma Centre.

"There has been a need for innovative approaches to ease this aspect of the treatment journey," he added. "The ability to administer a therapy through an on-body injector, particularly an anticancer drug, either in the clinic or eventually at a patient’s home, represents a meaningful step forward."

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.

Ramasamy also said that subcutaneous Sarclisa provides "an opportunity to reduce pressure on the NHS while placing greater flexibility and convenience at the heart of patient-centred care," noting that it aligns with the NHS 10-Year Plan and National Cancer Plan objectives to transform the healthcare system through technology.

"An automated 13-minute median duration injection that can be administered at home or in the clinic, with favourable patient comfort and satisfaction. This is what patient-centred innovation looks like in practice," said John Forni, medical lead for Sanofi UK and Ireland.

"We are proud that the UK is the first country in the world to launch the CirCLIQ OBI."

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