PREVYMIS

批准信原文要点

These Prior Approval sNDAs provide for the following change to the labeling: To update CLINICAL PHARMACOLOGY, Microbiology subsection with the additional phenotypic analysis data for letermovir against HCMV with the pUL56 (S229Y or M329I) and to remove information regarding pUL89 (D344Y) substitutions from the Prescribing Information.

批准信原文要点

NDA 209939/S-016 To expand the use of Prevymis to include pediatric kidney transplant recipients 12 years of age and older and weighing at least 40 kg; To update WARNINGS AND PRECAUTIONS with section 5.2 Risks Associated with Hydroxypropyl Betadex Excipient in Intravenous Formulation.

批准信原文要点

NDA 209939/S-013 • To expand the use of Prevymis to include pediatric NDA 209940/S-012 hematopoietic stem cell transplant recipients 6 months of age and older and weighing at least 6 kg • To update WARNINGS AND PRECAUTIONS with section 5.2 Risks Associated with Hydroxypropyl Betadex Excipient in Intravenous Formulation

批准信原文要点

These Prior Approval sNDAs provide for the following: To allow for extension of the Prevymis dosing regimen from 100 to 200 days post-transplant for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV seropositive recipients (R+) of an allogeneic hematopoietic stem cell transplant who are at risk for late CMV infection and disease.

批准信原文要点

These Prior Approval sNDAs provide for the following: • The use of Prevymis for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).

批准信原文要点

These Prior Approval sNDAs provide for the following: • To allow for extension of the Prevymis dosing regimen from 100 to 200 days post-transplant for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV seropositive recipients (R+) of an allogeneic hematopoietic stem cell transplant who are at risk for late CMV infection and disease

批准信原文要点

These Prior Approval supplemental new drug applications provide for the following revisions to the labeling of PREVYMISTM: • To update DRUG INTERACTIONS, Drugs without Clinically Significant Interactions with PREVYMIS and CLINICAL PHARMACOLOGY, Pharmacokinetics, Tables 5 and 6 with letermovir and itraconazole pharmacokinetic parameters, and to add the following statement: “Changes in letermovir plasma concentrations due to inhibition of P-gp/BCRP by itraconazole were not clinically relevant.”

批准信原文要点

These Prior Approval supplemental new drug applications provide for updating CLINICAL PHARMACOLOGY, Microbiology with the following information: • Resistance-associated substitutions identified in cell culture selection studies • Updated clinical resistance data from letermovir-treated subjects in the Phase 3 HSCT trial (P001), including a novel identified resistance-associated substitution.

批准信原文要点

These Prior Approval supplemental new drug applications provide for the following: To update DRUG INTERACTIONS section with information that PREVYMIS is a substrate of P-gp transporters and UGT1A1/3 enzymes and co-administration of PREVYMIS with inducers of transporters (e.g. P-gp) and/or enzymes (e.g. UGTs) is not recommended due to the potential for decrease in letermovir plasma concentrations.

批准信原文要点

These Prior Approval supplemental new drug applications provide for the following:  To update DRUG INTERACTIONS, Drugs without Clinically Significant Interactions with PREVYMIS, section with fluconazole information.  To update CLINICAL PHARMACOLOGY, Pharmacokinetics Tables 5 and 6 with fluconazole information.