Us Fda Approves Takeda

Takeda Pharmaceutical Company Limited,A Global, Values-Based, R&D-Driven Biopharmaceutical Leader, Announced That The Us Food And Drug Administration (Fda) Has Approved Livtencity (Maribavir) For The Treatment Of Adults And Pediatric Patients (12 Years Of Age Or Older And Weighing At Least 35 Kg) With Post-Transplant Cytomegalovirus (Cmv) Infection/Disease That Is Refractory To Treatment (With Or Without Genotypic Resistance) With Ganciclovir, Valganciclovir, Cidofovir, Or Foscarnet.Overall, More Than Twice The Proportion Of Adult Transplant Patients With Refractory Or Resistant (R/R) Cmv Infection/Disease Achieved Confirmed Cmv Dna Level 10% Of Patients Receiving Maribavir Were Taste Disturbance, Nausea, Diarrhea, Vomiting, And Fatigue. A Higher Proportion Of Subjects In The Iat Group Discontinued Study Medication Due To An Adverse Event Compared To The Livtencity Group (32%, N=37/116 Versus 13%, N=31/234, Respectively). Taste Disturbance Events (46%, N=108/234) Were Generally Mild, And Rarely Led To Discontinuation Of Maribavir (1%). In 37% Of Patients, These Events Resolved While Patients Remained On Therapy (Median Duration 43 Days; Range 7 To 59 Days).1 For The Patients With Ongoing Taste Disturbance After Drug Discontinuation, Resolution Occurred In 89%. In Patients With Resolution Of Symptoms After Drug Discontinuation, The Median Duration Of Symptoms Off Treatment Was 6 Days (Range 2 To 85 Days). All-Cause Mortality Was Similar In Each Treatment Group (Livtencity 11%, N=27/235; Iat 11%, N=13/117).Livtencity (Maribavir), An Orally Bioavailable Anti-Cmv Compound, Is The First And Only Antiviral Agent That Targets And Inhibits The Pul97 Protein Kinase And Its Natural Substrates. It Is Approved In The Us For The Treatment Of Adults And Pediatric Patients (12 Years Of Age Or Older And Weighing At Least 35 Kg) With Post-Transplant Cytomegalovirus (Cmv) Infection/Disease That Is Refractory To Treatment (With Or Without Genotypic Resistance) With Ganciclovir, Valganciclovir, Cidofovir Or Foscarnet.

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