Rezolute receives PRIME eligibility from EMA for RZ358

Rezolute announced that the European Medicines Agency, EMA, has granted Priority Medicines, PRIME, eligibility to RZ358 for the treatment of congenital hyperinsulinism, HI. PRIME eligibility is granted by EMA to drug candidates that target an unmet medical need and show potential benefit for patients based on clinical trial results. The PRIME initiative was created to provide proactive and enhanced support to developers of promising medicines to optimize development plans and accelerate evaluation with the goal of having new therapies reach patients faster. With respect to congenital HI, EMA has stated that there is an unmet medical need with no specifically authorized therapeutics available for the condition and that there are significant short-term and long-term risks, which are consequences of severe hypoglycemia. “We are excited to receive PRIME eligibility for RZ358, especially as we plan to initiate our Phase 3 study for RZ358 this quarter,” remarked Susan Stewart, JD, Chief Regulatory Officer at Rezolute. “We are appreciative that the EMA recognizes the devastating nature of the disease and the potential for RZ358 to have a significant positive impact on clinical outcomes for patients and their families.”