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.
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In an investigation that spans 12 companies and 24 drugs, Evercore ISI’s Umer Raffat said he believes Teva could face a liability of $300 million to $700 million, while Mylan could face a $380 million to $770 million liability. Those numbers are strictly based on the drugs “most likely” to be involved in the probe of which Raffat and company “are aware.”
Brincidofovir, the antiviral drug at the center of a compassionate use “Right To Try” social media storm in 2014 has failed in a Phase 3 clinical trial to prevent reactivation of cytomegalovirus (CMV) infections in patients undergoing hematopoietic stem cell transplants.
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