Cabaletta Bio, Inc., a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, announced on May 6, 2020 that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for DSG3-CAART (Desmoglein 3 Chimeric AutoAntibody Receptor T cells), the Company’s lead product candidate for treatment of mucosal pemphigus vulgaris (mPV), for improving healing of mucosal blisters in patients with mPV.
“We believe that this Fast Track Designation, coming shortly after the Orphan Drug Designation for DSG3-CAART, further demonstrates that mPV is a devastating, rare disease for which patients have limited treatment options resulting in a large unmet need. The Fast Track Designation represents an important next step in our clinical development plans,” said David J. Chang, M.D., Chief Medical Officer of Cabaletta. “We appreciate the benefits provided by this designation, including the opportunity for increased access to the FDA and potential acceleration of our clinical development path and regulatory review process.”
The FDA grants Fast Track Designation to drugs or biologics to facilitate the expedited development and review for therapeutics intended to treat serious or life-threatening conditions and to address unmet medical needs. Companies that receive Fast Track Designation are eligible for several potential benefits including the opportunity for more frequent meetings and interactions with the FDA during clinical development as well as eligibility for accelerated approval and/or priority review, if relevant criteria are met. Companies may also be allowed to submit sections of their Biologics License Application (BLA) on a rolling basis.