The FDA granted Shire’s Phase III-stage drug maribavir (SHP620) Breakthrough Therapy Designation for treating cytomegalovirus (CMV) infection and related disease in transplant patients who are resistant or refractory to previous therapy. Maribavir is a benzimidazole riboside compound, which is designed to target the key CMV UL97 protein kinase enzyme and so block viral DNA replication and encapsidation, which prevents viral capsid release from the nucleus of infected cells. The drug is being tested in patients who have CMV infection following hematopoietic stem cell or solid organ transplantation.
Breakthrough Therapy Designation status for maribavir was granted based on the data from two Phase II studies. In one study involving 120 CMV-infected patients aged 12 years or more, 67% of participants treated with varying doses of maribavir for up to 24 weeks had no detectable levels of the virus in their blood plasma within six weeks of starting treatment. The most commonly reported treatment-related adverse event (AE) was taste disturbance, although other treatment-emergent AEs reported in 5% or more of the study participants receiving any dose of maribavir included nausea, increased levels of immunosuppressant drugs, CMV infection, diarrhea, rash, vomiting, anemia, and pruritis (itch).
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