EMA PRIME designation for the Spanish Hospital’s CAR-T Product ARI-001 for Acute Lymphoblastic Leukaemia (ALL)

The PRIME designation was given on 16 December 2021 to Hospital Clínic’s ATMP for the treatment of patients older than 25 years with relapsed/refractory acute lymphoblastic leukaemia.

PRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need.

On February 2021 the Authorization of Use (Hospital Exemption) for ARI-0001 was given by Spain’s national regulator, AEMPS.

The PRIME eligibility granted to ARI-001 signifies potential future registration for the CAR-T product of competitive interest to Tecartus® in adult patients for the ALL indication.

Fonte: sito EMA