Enable Injections, a Cincinnati medical-device company behind the enFuse on-body delivery system, just helped make a bit of FDA history. Federal regulators have cleared a cancer therapy to be delivered through a wearable injector instead of the usual hours-long IV drip. The decision shifts Sanofi’s Sarclisa from marathon clinic infusions to a short, hands-free subcutaneous dose that patients can receive outside the infusion chair, right as Enable ramps up manufacturing and hiring across Greater Cincinnati.
What the FDA cleared
According to Sanofi, the FDA approved Sarclisa Escena, the subcutaneous formulation of isatuximab, to be administered using the CirCLIQ on-body injector that was developed with Enable’s enFuse platform. Sanofi called the decision “the first anticancer treatment to be administered through an on-body injector” and said the CirCLIQ option will sit alongside traditional manual subcutaneous dosing.
Local reaction and hiring
Cincinnati Business Courier coverage framed the FDA action as a milestone moment for the local unicorn and reported that Enable has been “hiring in droves” across the region. The approval lines up neatly with the company’s recent build-out plans as it gears up for commercial launches.
Sanofi bet and local manufacturing
Earlier this year, Enable announced that Sanofi had made a 30 million dollar strategic investment to speed up the company’s manufacturing build-out and reinforce its supply-chain capabilities. In a company statement, CEO Michael D. Hooven said the funding “shows support of the enFuse platform,” and Enable pointed to plans for a Springdale manufacturing center along with an expanded headquarters in Evendale. Enable Injections lays out the investment details and growth roadmap.
Platform track record
Enable’s enFuse platform already has a commercial win under its belt. Apellis’ EMPAVELI Injector, developed in collaboration with Enable, received FDA clearance in 2023 as a single-use on-body injector for subcutaneous dosing. Apellis notes that the EMPAVELI Injector was built on Enable’s enFuse syringe transfer system and enabled at-home self-administration for patients with PNH.
Patient and clinical impact
Industry coverage indicates that the subcutaneous Sarclisa regimen delivered by a wearable device cuts administration times dramatically and could ease pressure on crowded infusion centers, while keeping efficacy comparable to IV dosing. Bio-IT World and other outlets highlighted trial data showing nearly identical response rates for IV and subcutaneous Sarclisa. Sanofi’s materials also report that injection-site reactions were uncommon, at roughly 0.4 percent of more than 5,000 injections, and most were mild.
Regulatory note
Because CirCLIQ pairs a biologic with a delivery device, the product is regulated as a combination product, which triggers coordinated premarket review and post-market obligations overseen by the FDA’s Office of Combination Products. The agency has issued guidance clarifying the evidence and human-factors testing that sponsors must provide for device-enabled drug delivery systems. FDA resources lay out how those cross-center reviews work.
For Cincinnati, the approval and Sanofi’s strategic investment are poised to translate into years of manufacturing work and hiring as Enable scales for commercial launches. State materials show that Enable has committed to adding roughly 257 new positions and investing about 124 million dollars in its regional expansion plans. JobsOhio documents the company’s expansion commitments.
