EU regulator backs use of Merck's viral infection drug

Bengaluru: Merck & Co said on Tuesday the European Union medicines regulator recommended a marketing authorisation for the company's drug Prevymis to treat a type of infection in adult kidney transplant recipients at high risk.

The drugmaker says Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) also recommended the approval for extending dosing of the drug to 200 days from 100 days, following a type of transplant in adult patients.

A final decision on the extended use of the drug is expected this year.

Prevymis is an antiviral agent that was initially approved by the U.S. Food and Drug Administration (FDA) in 2017 and by the EMA in 2018 for prevention of a type of viral infection called Cytomegalovirus (CMV) in some patients who have received a type of stem-cell transplantion.