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Merck Gets FDA Approval Of Prevymis For Prevention Of CMV Infection

Merck & Co., Inc. (MRK), known as MSD outside the United States and Canada, said that the U.S. Food and Drug Administration has approved Prevymis or letermovir once-daily tablets for oral use and injection for intravenous infusion.

Prevymis is indicated for prophylaxis or prevention of cytomegalovirus or CMV infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT).

CMV is a common and potentially serious viral infection in allogeneic HSCT recipients. CMV-seropositive patients who undergo an HSCT are at high risk for CMV reactivation. Any level of CMV infection is associated with increased mortality in HSCT patients.

In the pivotal Phase 3 clinical trial supporting approval, significantly fewer patients in the Prevymis group, or 38 percent, compared to the placebo group or 61 percent, developed clinically significant CMV infection, discontinued treatment or had missing data through Week 24 post-HSCT, the primary efficacy endpoint.

Prevymis is expected to be available in December. The list price per day for Prevymis tablets is $195.00 and for Prevymis injection is $270.00. Wholesaler acquisition costs do not include discounts that may be paid on the product.

by RTT Staff Writer

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