Please login to the form below

Not currently logged in

Shire’s Maribavir wins US breakthrough therapy designation

It's based on phase II data for the transplant infection treatment

ShireThe 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.

Article by
Gemma Jones

8th January 2018

From: Research



Featured jobs

Subscribe to our email news alerts


Add my company
Hanson Zandi

Hanson Zandi is a Creative and Digital Healthcare Agency. We combine 30 years’ experience with the enthusiasm of a start-up...

Latest intelligence

AstraZeneca’s oncology renaissance
Susan Galbraith played a key role in restoring AstraZeneca’s place in cancer drug development – she talks about the future of oncology and why there’s more to be done to...
Navigating the antibiotic resistance crisis
Blue Latitude Health speaks to Tara DeBoer, PhD, Postdoctoral Researcher and CEO of BioAmp Diagnostics to explore the antimicrobial resistance crisis, and learn how a simple tool could support physicians...
Combined immunotherapies – potential and pitfalls
‘Combining therapeutic compounds is the first logical step towards better results, namely higher rates of patients responding to treatment, with deeper and more sustained responses’...