EU clears MSD’s Prevymis for CMV prevention

European regulators have approved MSD’s Prevymis for the prevention of cytomegalovirus (CMV) reactivation and disease in prone adults who have received an allogeneic haematopoietic stem cell transplant (HSCT).

Around 50-80 percent of adults in the UK are thought to be infected with CMV, which can remain in the body in an inactive or latent state, potentially becoming reactivated if the immune system is compromised.

As such, CMV infection is a common complication in patients taking immunosuppressants as part of a HSCT regimen, and reactivation of the virus after transplant is linked with serious complications and increased mortality.

Prevymis (letermovir) is a first-in-class antiviral drug that inhibits CMV replication.

According to Phase III data, significantly fewer patients taking the drug (38 percent) compared to those given a placebo (61 percent) developed clinically significant CMV infection, discontinued treatment or had missing data through Week 24 post-HSCT.

Also, all-cause mortality in patients receiving Prevymis was lower compared to placebo at 12 percent versus 17 percent, respectively, 24 weeks post-transplant.

"MSD is delighted that the EC has recognised the potential of letermovir for prophylaxis of cytomegalovirus (CMV) reactivation in certain patients in need of a new option," said Louise Houson, UK managing director, MSD.

"This authorisation brings us a step closer to making letermovir available in the UK and we will continue to work closely with NICE, NHS, SMC and other relevant stakeholders to help ensure that appropriate patients have access to letermovir as soon as possible."

The drug was approved in the US for CMV prevention in November last year.

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