FDA accepts supplemental new drug application for Prevymis for priority review
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Merck announced the FDA accepted two supplemental new drug applications for Prevymis, also known as letermovir, and granted the application priority review, according to the press release.
An additional supplemental new drug application was accepted for review for extending the use of the treatment from 100 days to 200 days among adults receiving an allogeneic hematopoietic stem cell transplant (HSCT) and who are at risk for late cytomegalovirus (CMV) infection or disease.
According to the release, the drug is a first-in-class antiviral agent intended to extend prophylaxis of CMV disease in adult kidney transplant recipients at high risk.
In a phase 3, randomized, double-blind clinical trial, letermovir showed noninferior efficacy and a better safety profile than valganciclovir among kidney transplant recipients with CMV. The drug also showed superior efficacy and safety than a placebo in a phase 3, randomized, double-blind, placebo-controlled trial extending prophylaxis with letermovir from 100 to 200 days in kidney transplant recipients who were CMV-seropositive at high risk for CMB infection following a HSCT.
“Certain high-risk individuals who develop CMV infection following receipt of a kidney transplant are at increased risk for transplant failure and death. Prevymis has the potential to be an important new option with a favorable safety profile for patients at risk for CMV infection following a kidney transplant,” Nicholas Kartsonis, MD, senior vice president of vaccines and infectious diseases in global clinical development at Merck Research Laboratories, said in the release. “We look forward to the FDA’s review of our filings for Prevymis.”
The Prescription Drug User Fee Act, or target action dates, are June 5 and Sept. 7.
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