In this phase 2 study, we evaluated the effect of letermovir (also known as AIC246), a new anti-CMV drug with a novel mechanism of action, on the incidence and time to onset of prophylaxis failure ...

Study 2, using a specific assay for the active and main component in the plasma, namely 17-BMP, was needed to confirm definitive results. Because of the difficulty in developing the specific assay ...

The randomized, placebo-controlled study will evaluate the safety and efficacy of letermovir in approximately 540 patients from more than 70 centers in 20 countries, including the United States.

Merck has announced positive results from its Phase 3 trial of letermovir, an investigational antiviral medicine for the prevention of clinically-significant cytomegalovirus (CMV) infections in ...

However, in that study, there was an increased incidence of clinically significant cytomegalovirus infection observed between 100 days and 200 days after letermovir was discontinued at 100 days.

The drug's manufacturer, Merck, announced today that the FDA also approved letermovir for CMV prophylaxis in adult kidney transplant recipients at high risk, based on results of the current study.

Merck’s Letermovir, an Investigational Antiviral Medicine for Prevention of Cytomegalovirus (CMV) Infection in Bone Marrow Transplant Recipients, Highly Effective Through Week 24 Post-Transplant ...

--Unicycive Therapeutics, Inc., a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the primary endpoint was met in the Company’ s ...

FDA now recommends only one study to show bioequivalence for certain oral drug products - FDA also revises several hundred product specific guidances to align with ICH M13A BE standards ...

The study enrolled 40 subjects per treatment arm. The study design, including the dose, primary endpoint, and sample size, was reviewed, and aligned by the FDA before the initiation of the study.