Merck gets USFDA priority review for PREVYMIS for Prophylaxis of Cytomegalovirus Disease in kidney transplant recipients at high risk

Published On 2023-02-19 11:00 GMT   |   Update On 2023-02-19 11:01 GMT
Advertisement

Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental new drug applications (sNDA) for PREVYMIS (letermovir).

The FDA granted priority review for the sNDA for PREVYMIS for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (D+/R-); the Prescription Drug User Fee Act (PDUFA), or target action date, is June 5, 2023. The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition. A second sNDA to extend use of PREVYMIS from 100 days to 200 days in adults receiving an allogeneic hematopoietic stem cell transplant (HSCT) who are at risk for late CMV infection and disease was also accepted for review, with a PDUFA date of Sept. 7, 2023.

Advertisement

“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,” said Dr. Nicholas Kartsonis, senior vice president, vaccines and infectious diseases, Global Clinical Development, Merck Research Laboratories. “We look forward to the FDA’s review of our filings for PREVYMIS.”

PREVYMIS is a first-in-class antiviral agent that was approved by the U.S. FDA in 2017 and is indicated for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). PREVYMIS is also approved in more than 60 countries outside of the United States, including EU member states, Canada, Japan and China. 

Read also: MSD Pharma likely to participate in global tender for procurement of HPV vaccine against cervical cancer

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News