Vericel Announces Plan to Submit Biologics License Application to the FDA
Vericel Corporation recently announced that following discussions with the US Food and Drug Administration (FDA), the company plans to submit a Biologics License Application (BLA) to the FDA by the end of 2015 for MACI for the treatment of focal chondral cartilage defects in the knee.
“We have had very productive discussions with the FDA regarding the regulatory pathway for the submission of the MACI BLA in the United States,” said David Recker, MD, Chief Medical Officer of Vericel. “Our planned MACI BLA submission reflects Vericel’s commitment to deliver innovative therapies for patients with serious cartilage injuries in the knee.”
MACI (matrix-applied characterized autologous cultured chondrocytes) is a third-generation autologous chondrocyte implantation (ACI) product for the treatment of cartilage defects in the knee. MACI was the first tissue-engineered product approved under the Advanced Therapy Medicinal Product guidelines by the European Commission. The pivotal Phase III clinical trial supporting MACI registration in Europe (the Superiority of MACI Implant to Microfracture Treatment, or SUMMIT study) demonstrated a statistically significant and clinically meaningful improvement in the co-primary endpoint of pain and function for patients treated with a MACI implant compared to microfracture at 2 years.
Vericel Corporation (formerly Aastrom Biosciences, Inc.) is a leader in developing patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions. The company markets two autologous cell therapy products in the US: Carticel (autologous cultured chondrocytes), an autologous chondrocyte implant for the treatment of cartilage defects in the knee, and Epicel (cultured epidermal autografts), a permanent skin replacement for the treatment of patients with deep-dermal or full-thickness burns comprising greater than or equal to 30% of total body surface area. For more information, visit www.vcel.com.
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