- Atara Biotherapeutics ( NASDAQ: ATRA ) transfered the European Commission (EC) marketing authorization (MA) of Ebvallo to Pierre Fabre.
- The two companies' drug Ebvallo (tabelecleucel) was approved in December 2022 by EC to treat patients two years of age and older with relapsed or refractory 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.
- PTLD is a life-threatening complication following solid organ or bone marrow transplantation.
- Pierre will lead all commercialization, distribution, medical and regulatory activities in Europe, Middle East, Africa and other selected markets. The French company is planning to launch the drug in certain European countries in Q1 2023.
- South San Francisco-based Atara noted that it retains full rights to Ebvallo in other major markets, including North America, Asia Pacific, and Latin America.
- Atara will also continue to be responsible for a study called ALLELE in PTLD and a phase 2 trial of the drug in additional patient populations.
- The approval was backed by data from the phase 3 trial, ALLELE, and additional supportive studies, according to the companies.
- The EC decision followed a recommendation of approval by a panel of the European Medicines Agency in October 2022.
- ATRA +2.01% to $5.57 premarket Feb. 8
For further details see:
Atara transfers rights for Ebvallo to Pierre Fabre in EU, certain other markets