Merck’s Prevymis Received positive EU’s CHMP Opinion for the prophylaxis of cytomegalovirus
Shots:
- The EMA's CHMP adopted positive opinion recommending Prevymis (letermovir) for CMV prophylaxis in high-risk adult kidney transplant recipients & extends its dosing from 100 to 200 days for bone marrow transplant pts who are at risk for late CMV infection. EC’s final decision is expected by YE 2023
- The opinion regarding use of prevymis as CMV disease prophylaxis was based on P-III trial (NCT03443869) having 567 high risk adult kidney transplant recipients. Additionally, the opinion of extending Prevymis dosing from 14 wks. to 28 wks. post HSCT was based on another P-III trial (NCT03930615)
- Prevymis is an antiviral agent already approved by FDA for CMV disease prophylaxis in high-risk adult kidney transplant pts. and has extended 200-day dosing as CMV prophylaxis in HSCT recipients
Ref: Merck | Image: Merck
Related News:- Merck’s Prevymis (letermovir) Receives the US FDA’s Approval for Prevention of Cytomegalovirus Disease
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
