US FDA approves Merck’s PREVYMIS tablets

The US Food and Drug Administration (FDA) has approved Merck’s PREVYMIS (letermovir) tablets for oral use and injection for intravenous infusion.

The once-daily PREVYMIS is indicated for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

CMV is a common and potentially serious viral infection in allogeneic HSCT recipients and any level of infection is associated with increased mortality in HSCT patients.

PREVYMIS is contraindicated in patients receiving pimozide or ergot alkaloids. Increased concentrations of pimozide may lead to QT prolongation and torsades de pointes, while high doses of ergot alkaloids concentrations may lead to ergotism.

Merck Research Laboratories senior vice-president, head of clinical development, and chief medical officer Dr Roy Baynes said: “PREVYMIS is the first new medicine for CMV infection approved in the US in 15 years.

“PREVYMIS continues Merck’s longstanding tradition of bringing forward important new therapies to address serious infectious diseases. We are proud to add this breakthrough medicine to our existing offerings for physicians and patients.”

The concomitant use of the tablets and certain drugs may result in potentially significant drug interactions.

Some of them may lead to adverse reactions or reduced therapeutic effect of PREVYMIS or the concomitant drug.

Significantly fewer patients in the PREVYMIS group compared to the placebo group in the pivotal Phase III clinical trial supporting approval, developed clinically significant CMV infection, discontinued treatment or had missing data through Week 24 post-HSCT.

Compared to placebo at week 24 post-transplant, all-cause mortality in patients receiving PREVYMIS was lower.

 

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