EMA awards coveted PRIME designation for Janssen's CAR-T therapy

5 April 2019

The European Medicines Agency has granted a PRIME (PRIority MEdicines) designation for the investigational B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, JNJ-68284528 (JNJ-4528), from Johnson & Johnson (NYSE: JNJ) subsidiary Janssen.

PRIME offers enhanced interaction and early dialogue to optimize development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need, similar to the USA’s Breakthrough Therapy designation.

“The PRIME designation of this novel BCMA CAR-T therapy highlights the value of regulatory innovation in the European Union,” said Sjaak Bot, vice president, head EMEA regulatory affairs at Janssen Biologics BV, adding: “We hope to bring this important advance to patients as quickly as possible and this PRIME designation, the first for Janssen, marks an important milestone towards potential market approval.”

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