US FDA accepts for priority review the supplemental new drug application for Merck’s Prevymis for prophylaxis of cytomegalovirus disease in kidney transplant recipients at high risk

Merck/MSD

17 February 2023 - FDA also accepts a separate supplemental application to extend prophylaxis with Prevymis to 200 days in certain HSCT recipients.

Merck today announced the US FDA has accepted for review two supplemental new drug applications for Prevymis (letermovir).

Read Merck press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review , Dossier