Merck Sharp and Dohme’s Prevymis receives CHMP backing for EU approval

Merck Sharp and Dohme has announced that its drug Prevymis has been recommended by Europe's Committee for Medicinal Products for Human Use (CHMP) for regulatory approval.

The European Medicines Agency committee has adopted a positive opinion recommending approval of Prevymis for the prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients of an allogeneic haematopoietic stem cell transplant.

This decision is based on the findings of a pivotal phase III clinical trial evaluating the drug,  which showed that significantly fewer patients receiving Prevymis developed clinically significant CMV infections, discontinued treatment or had missing data 24 weeks after the transplant that those on placebo.

Prevymis was approved in this indication by the US Food and Drug Administration earlier this month, with regulatory approvals in other markets such as Japan still pending.

The compound was acquired by Merck Sharp and Dohme from AiCuris in 2012, and is part of a new class of non-nucleoside CMV inhibitors that blocks viral replication by specifically targeting the viral terminase complex.

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