Takeda’s LIVTENCITY TM (maribavir) Approved by U.S. FDA as the First and Only Treatment for People Ages 12 and Older with Post-Transplant Cytomegalovirus (CMV), Refractory (With or Without Genotypic Resistance) to Conventional Antiviral Therapies November 23, 2024 See more Takeda Patient Support is available to help patients prescribed LIVTENCITY gain access to their medication, find educational … See more Takeda is positioned to deliver near-term growth through global brand expansions and its Wave 1 pipeline, which includes multiple first-in-class new molecular entities (NMEs) with potential for approval through FY2024. The … See more The TAK-620-303 (SOLSTICE) trial (NCT02931539) was a multicenter, randomized, open-label, active-controlled superiority trial to … See more CMV is a beta herpesvirus that commonly infects humans; serologic evidence of prior infection can be found in 40%-100% of various adult populations.14 CMV typically resides latent and … See more WebMay 21, 2024 · Publish Date May 21, 2024 ... “If approved, maribavir has the potential to change the treatment landscape for post-transplant CMV, and the acceptance of this regulatory application is an ...
Search Orphan Drug Designations and Approvals - Food and …
WebNov 23, 2024 · Livtencity is a brand name of maribavir, approved by the FDA in the following formulation(s): LIVTENCITY (maribavir - tablet;oral) Manufacturer: TAKEDA … WebReview Completion Date November 4, 2024 Subject Evaluation of Need for a REMS Established Name Maribavir Trade Name Livtencity ... (13-0) for the approval of maribavir to treat refractory CMV infection in post-transplant patients with or without genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir. top eye clinic meyerland houston
UpToDate
WebLIVTENCITY (maribavir) tablets, for oral use Initial U.S. Approval: 2024 -----RECENT MAJOR CHANGES----- Dosage and Administration, Administration (2.3) 9/2024 ... approved patient labeling. Revised: 9/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION WebSep 16, 2024 · In November 2024, maribavir received U.S. Food and Drug Administration (FDA) approval, under the brand name LIVTENCITY TM, 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 … WebOct 21, 2024 · Date of entry onto ARTG 7 October 2024 Black triangle scheme Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia Dose forms Film coated tablet Strength 200 mg Other ingredients Tablet core: Magnesium stearate, microcrystalline cellulose, sodium starch glycolate top eyebrow serum