Fibrocell Announces FDA Fast Track Designation of FCX-013 for Treatment of Moderate to Severe Localized Scleroderma

- September 5th, 2018

Fibrocell Science (NASDAQ:FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to FCX-013, the Company’s clinical stage candidate for the treatment of moderate to severe localized scleroderma—a chronic, debilitating genetic skin disorder … Continued

Fibrocell Science (NASDAQ:FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to FCX-013, the Company’s clinical stage candidate for the treatment of moderate to severe localized scleroderma—a chronic, debilitating genetic skin disorder with no FDA approved therapies.

As quoted in the press release:

“Fast Track designation represents an important milestone in advancing clinical development of FCX-013,” said John Maslowski, President and Chief Executive Officer of Fibrocell. “We are pleased the FDA has awarded this designation to FCX-013 which, we believe, has the potential to be the first gene therapy to treat excessive collagen accumulation in the skin and soft tissue at the site of localized scleroderma lesions and to bring relief from the severe pain and functional disability associated with the disorder.”

The Fast Track program is designed to facilitate development and expedite review of new therapies that address unmet medical needs of patients with serious conditions.  The designation offers various benefits, including more frequent meetings with the FDA to discuss the drug’s development plan, eligibility for Accelerated Approval or Priority Review if relevant criteria are met, and opportunity for Rolling Review, which allows the Company to submit completed sections of its Biologics License Application (BLA) to the FDA, rather than waiting until every section of the BLA is completed before the entire application can be reviewed.

Click here to read the full press release.

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