FDA Grants Regenerative Medicine Designation to Humacyte Vascular Tissue Therapy

The FDA granted expedited review to Humacyte’s tissue therapy under the new Regenerative Medicine Advanced Therapy pathway — one of the first products to receive the designation established by the 21st Century Cures Act.

The RMAT is similar to the agency’s Breakthrough Therapy designation, granting early interactions with FDA officials and making the product eligible for accelerated approval. But it also allows a broader range of options for sponsors to meet postmarket requirements, including using real-world evidence sources such as electronic health records or larger confirmatory data sets.

Humacyte’s investigational human acellular vessel, Humacyl, is designed to increase vascular access in patients undergoing hemodialysis. The biologic received a Fast Track designation in 2014.

An international Phase III trial of Humacyl is underway, comparing the tissue-engineered vessel to a synthetic graft in 350 patients with kidney failure. Separately, a Phase II trial is exploring Humacyl’s use as a bypass graft in patients with peripheral artery disease.