Vertex Pharmaceuticals announced today that FDA has granted fast track designation for its VX-880, an investigational human stem cell-derived islet cell therapy for type 1 diabetes.
Vertex has begun a clinical trial for VX-880 (formerly known as STx-02) in patients with type 1 diabetes (T1D) with severe hypoglycemia and impaired hypoglycemia awareness.
“Ours is the only approach that produces fully differentiated and fully functional insulin-secreting pancreatic islets. We are very pleased to have received FDA’s fast track designation, which facilitates the development and expedites the review of drugs that treat serious conditions and fill an unmet medical need. We continue to work with urgency to bring this innovative therapy to patients,” said Bastiano Sanna, EVP and chief of cell and genetic therapies at Vertex.
Dr. Camillo Ricordi, director of the Diabetes Research Institute (DRI) and the Cell Transplant Center at the University of Miami, said in the same news release that it’s a remarkable time for type 1 diabetes research.
“The field’s experience with the limited cadaveric islet transplants available, where some patients have experienced prolonged insulin independence for years, provides important proof-of-concept for the potential of cell therapy to be transformative for patients living with T1D,” said Ricordi, who is the steering committee chair for the VX-880 clinical trial.