Pierre Fabre Pharmaceuticals Inc. announces the FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease

First Allogeneic T-Cell Therapy BLA Filing acceptance by U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) Target Action Date of January 15, 2025

If Approved, Tab-cel Would be the First Approved Therapy in U.S. for EBV+ PTLD and will be commercialized in the US by the newly established subsidiary Pierre Fabre Pharmaceuticals Inc.

The BLA is supported by data from the pivotal Phase 3 ALLELE study which was investigating Tab-cel in relapsed or refractory EBV+ PTLD following solid organ transplant (SOT) or hematopoietic cell transplant (HCT)

PARSIPPANY, N.J., July 18, 2024 /PRNewswire/ -- Pierre Fabre Pharmaceuticals Inc. announces the acceptance by U.S Food and Drug Administration (FDA) of the Biologics License Application (BLA) and Priority Review of Tabelecleucel (Tab-cel®), indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. There are no FDA approved therapies in this treatment setting.

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The BLA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of January 15, 2025.

"Patients facing relapsed or refractory EBV+ PTLD have no approved FDA treatment options, and with current therapeutic options their survival is unfortunately often measured in weeks or months. Today's BLA acceptance is a significant step towards making Tab-cel® available to patients in the United States. We congratulate our partner ATARA on this significant achievement and are now focused on preparing for potential FDA approval and launch of this innovative new treatment option for EBV+ PTLD." said Adriana Herrera, Chief Executive Officer of Pierre Fabre Pharmaceuticals Inc., the new Pierre Fabre Medical Care subsidiary in the United States. "Following international recognition on June 24 for Tab-cel® with the Galien International Prize, we know we are on the right path to embody our purpose: every time we take care for a single person, we make the whole world better."

CONTACT: Geoffrey Cook, [email protected]

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SOURCE Pierre Fabre Pharmaceuticals Inc.