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Find Clinical Drug Pipeline Developments & Deals by AiCuris
Prevymis™ (letermovir) was approved by the US FDA in 2017 and by the EMA and Japan’s PMDA in 2018 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant who are at high risk for CMV reactivation.
Receiving Breakthrough Therapy Designation will facilitate AiCuris goal of bringing pritelivir to patients as quickly as possible
. Company is now preparing to add a pivotal Phase 3 trial part to the ongoing Phase 2 study in immunocompromised patients.