FDA Accepts Vericel’s BLA for MACI for in Knee Cartilage Defects

By Julie A. Vetalice

FDA has accepted for filing Vericel's Biologics License Application for MACI™ (matrix applied characterized autologous cultured chondrocytes), an investigational autologous cellular product intended to treat adult symptomatic knee cartilage defects.  FDA provided a PDUFA (Prescription Drug User Fee Act) goal date of 1/3/17, and does not plan to convene an advisory committee meeting to discuss the application.

Vericel submitted the BLA in early January 2016.

Source: Vericel Corporation

Product Labels: Orthobiologic Soft Tissue Repair

Tags: Regulatory