BRIEF—Shire's CMV candidate granted breakthrough status

Rare diseases specialist Shire has received US Food and Drug Administration (FDA) Breakthrough Therapy Designation for maribavir (SHP620), a Phase III investigational treatment for cytomegalovirus (CMV) infection and disease in transplant patients resistant or refractory to prior therapy.

CMV is a common virus that infects people of all ages. In the USA, by age 40, more than half of adults have been infected with CMV, most showing no signs or symptoms. However, in people with compromised immunity, CMV infection is a serious clinical complication that can lead to tissue-invasive disease and ultimately be fatal.

By targeting a key CMV enzyme, maribavir is thought to inhibit CMV DNA replication and encapsidation, and prevent the escape of viral capsids from the nucleids of infected cells.

Andreas Busch, global head of research and development at the Ireland-headquartered company, said: “Maribavir has the potential to address critical medical needs for transplant patients who are refractory or resistant to currently available antiviral therapies, and I’m proud of the innovation and hard work that made this Breakthrough Designation Therapy milestone a reality.”