The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of MSD’s Prevymis (letermovir) for the prophylaxis of cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients.
Many adults have CMV antibodies in their blood, meaning they have been previously exposed to CMV – a common virus that is usually harmless. However, CMV-seropositive patients are at risk of virus reactivation during a kidney transplant, and a donor can pass on the virus to a CMV-seronegative recipient.
Prevymis is already approved in more than 60 countries for use in CMV-seropositive patients who have received an allogeneic haematopoietic stem cell transplant (HSCT). The drug works by inhibiting the DNA terminase complex in CMV cells, an enzyme important in DNA maturation and packaging. Inhibition of the complex prevents the virus from replicating.
In June 2023, the US Food and Drug Administration expanded the approval of the drug for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk. A month later, it also recommended the Prevymis dose extension in HSCT recipients with late CMV infection and disease risk.
The CHMP recommendation could now expand the approval to patients at risk of CMV infection during kidney transplants in the EU. The recommendation will now be reviewed by the European Commission for marketing authorisation in the European Union (EU), with a decision expected later this year, per a 17 October press release.
The positive CHMP decision also included a recommendation to extend the dose of the drug from 100 days to 200 days in CMV-seropositive patients who have had an allogeneic HSCT and are at risk of late CMV infection and disease.
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By GlobalData
Prevymis had global sales of $428m in 2022, according to MSD’s full-year financial results.
MSD’s global clinical development vice-president Dr Elizabeth Rhee said: “CMV is a potentially serious viral infection for these high-risk transplant recipients, and we are pleased that these patients in the EU will soon be able to access Prevymis to help prevent CMV infection and disease.”
