(News Bulletin 247) – Merck today announced that the US Food and Drug Administration (FDA) has agreed to review two Supplemental New Drug Applications (sNDAs) for PREVYMIS.
The FDA granted priority review to the sNDA for PREVYMIS for the prophylaxis of cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients. The target action date, or Prescription Drug User Fee Act (PDUFA), is June 5, 2023.
A second sNDA to extend the use of PREVYMIS from 100 to 200 days in adults receiving allogeneic hematopoietic stem cell transplantation (HSCT) and at risk of infection and late-onset CMV disease was also accepted for review, with a PDUFA date set for September 7, 2023.
‘Some high-risk people who develop CMV infection after receiving a kidney transplant have an increased risk of transplant failure and death. PREVYMIS has the potential to be an important new option with a favorable safety profile for patients,” said Dr. Nicholas Kartsonis, senior vice president at Merck. And to wait ‘impatiently’ for the FDA’s review of applications for approval of PREVYMIS.
Copyright (c) 2023 News Bulletin 247. All rights reserved.
I have over 8 years of experience working in the news industry. I have worked as a reporter, editor, and now managing editor at 247 News Agency. I am responsible for the day-to-day operations of the news website and overseeing all of the content that is published. I also write a column for the website, covering mostly market news.
