Shire's Late-Stage CMV Drug Wins FDA Breakthrough Therapy Designation

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 bei