Cincinnati’s top venture-backed startup Enable Injections has received its first stamp of approval from the U.S. Food and Drug Administration.
Effective Oct. 2, the FDA has given its OK to the Empaveli injector, which was developed based on the Evendale-headquartered medical device maker’s EnFuse technology.
The device allows for the subcutaneous on-body delivery of Empaveli, or pegcetacoplan, a drug being commercialized in the states by Waltham, Mass.-based Apellis Pharmaceuticals. Empaveli is for use in adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disease.
The approval is a major step forward for Enable following “more than a decade of research, development and manufacturing in the Cincinnati area,” Mike Hooven, the company’s chairman and CEO, said in a statement to Cincy Inno.
Enable, founded in 2010 by Hooven and team, has raised more than $314 million in capital in its quest to commercialize its device, including a $215 million Series C in January 2022, the largest round ever in the region.
The EnFuse, Hooven said, is poised to be a major health care disruptor. The wearable, compact, palm-sized circular disk can deliver a drug more quickly than traditional IV administration, and a patient can complete the treatment at home, versus at a clinic, and at much lower cost, improving the overall patient experience.
“This achievement marks an important milestone for Enable Injections, as we enter the next phase as a company and launch commercially with our partners,” Hooven said. “The Cincinnati region and state of Ohio have been tremendous partners in our developing the EnFuse technology and the Enable Injections business. We appreciate all the support from our local organizations, and we look forward to expanding our business here in Cincinnati as we anticipate significant growth with additional partners and products.”
The Empaveli injector, according to a news release, offers several advances to streamline drug self-administration.
Enable has developed and manufactured the EnFuse to deliver high-volume pharmaceutical and biologic therapeutics via subcutaneous, or under the skin, administration using a hands-free, hidden needle drug delivery system.
A push button starts the injection, and the needle automatically retracts upon dose completion.
The device is a first of its kind.
“Empaveli continues to demonstrate its potential to elevate the standard of care … Now, we are further enhancing the patient experience with the approval of the Empaveli injector,” Peter Hillmen, a rare disease adviser with Apellis, said in a news release. “This approval is an example of how we are continually innovating with patients at the forefront.”
In addition to Apellis Pharmaceuticals, Enable has major public partnerships with drugmaker Sanofi, a collaboration that’s backed by famed investment group Blackstone; Pennsylvania-based biopharmaceutical company CSL Behring; Genentech/Roche Group; and Viridian Therapeutics, also based in Waltham, which is advancing multiple candidates for the treatment of thyroid eye disease.
Enable currently has around 200 employees and is looking to more than double its headcount locally by calendar year 2027 as it anticipates more FDA approvals.
The team continues to scout out a spot to build a new 150,000-square-foot headquarters to accommodate that growth. A spokeswoman told me there are no updates about a target location.
