Enforcement Report - Week of February 22, 2023
Enforcement Report - Week of January 4, 2023
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the United States commercial availability of LIVTENCITY™ (maribavir), the first and only treatment for adults and pediatric patients (12 years of age and 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.1 LIVTENCITY, an orally bioavailable anti-CMV compound, became available for prescription on December 2, 2021, just over a week after the U.S. Food and Drug Administration (FDA) approval which took place on November 23, 2021.
OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. 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.1 Overall, more than twice the proportion of adult transplant patients with refractory or resistant (R/R) CMV infection/disease achieved confirmed CMV DNA level <LLOQ* (lower limit of quantification, i.e. <137 IU/mL) at Week 8 (end of treatment phase), the study’s primary endpoint, with LIVTENCITY (56%; n=131/235), compared to those treated with conventional antiviral therapies (24%; n=28/117) (adjusted difference: 33%, 95% CI: 23–43; p<0.001).†‡§ LIVTENCITY is Takeda’s second new molecular entity to receive FDA approval in FY2021.
The FDA’s antimicrobial drugs advisory committee on Thursday voted unanimously in favor of FDA approving Takeda’s antiviral for post-transplant cytomegalovirus.
London, 22 June 2021 – Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, has launched Ganciclovir for Injection, USP, 500mg, in the US, through its US affiliate, Hikma Pharmaceuticals USA Inc.
OSAKA, Japan, June 7, 2021 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today at the American Transplant Congress (ATC) 2021 Virtual Connect presented results from a new subgroup analysis of SOT recipients in the Phase 3 TAK-620-303 (SOLSTICE) trial, for the investigational drug TAK-620 (maribavir). More than twice (55.6%, 79/142) as many SOT recipients with R/R CMV infection at baseline treated with maribavir achieved confirmed CMV viremia clearance at Study Week 8 (end of treatment phase) compared to those treated with conventional antiviral therapies (26.1%, 18/69) (investigator assigned treatment; IAT consists of one or a combination of ganciclovir, valganciclovir, foscarnet or cidofovir) (adjusted difference [95% CI]: 30.5% [17.3, 43.6]).1 The results presented showed consistent efficacy in SOT recipients receiving maribavir in heart, lung and kidney transplants.
FDA Action Alert: EyePoint Pharma and Merck