In March, the European Medicines Agency (EMA) launched the PRIME programme, a variation of the FDA's breakthrough designation programme aimed at speeding up the development of promising medicines with high potential to address unmet needs. They have now disclosed the first four PRIME candidates. Only one of these drugs (KTE-C19) has been publicly disclosed as having breakthrough designation.

The first four PRIME candidates are: Biogen's aducanumab, a beta-amyloid targeting antibody for Alzheimer disease; Kite Pharma's KTE-C19, a chimeric antigen receptor (CAR) T cell therapy for diffuse large B cell lymphoma; ChemoCentryx's CCX168, a C5a receptor inhibitor for a set of rare autoimmune diseases called ANCA-associated vasculitis; and Novimmune's NI-0501, an anti-interferon-γ antibody for the rare autoimmune disease haemophagocytic lymphohistiocytosis.

The agency denied PRIME designation to 14 submissions.

The EMA will disclose further PRIME candidates on a monthly basis.