The US Food and Drug Administration (FDA) has granted a breakthrough therapy designation to Shire’s investigational treatment for cytomegalovirus (CMV) infection in transplant patients.
The infection – categorised as a beta herpes virus – can cause clinically challenging complications, which can be fatal in patients with compromised immunity.
Despite existing antiviral therapies for this disease area, side effects or drug resistance may limit their use.
Maribavir (SHP620), however, could potentially treat transplant patients who are refractory or resistant to the standard of care.
Andreas Busch, global head of R&D at Shire, 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.”
According to Shire, the investigational treatment operates by targeting a key CMV enzyme and preventing the escape of viral capsids from the nucleids of infected cells.
Busch added: “We are delighted that the FDA has granted breakthrough therapy designation (BTD) to maribavir and we continue to work every day to delivery therapies to the patients who need them most.
“We are eager to work with the FDA to continue development of maribavir.”
The US regulator awarded the drug with the status based on data from two phase II studies, which saw 67% of patients treated with varying doses of maribavir for up to 24 weeks had no detectable levels of the virus within six weeks of starting treatment.