Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, failed to meet the primary endpoint of noninferiority compared to Roche Holding AG’s valganciclovir in the phase III Aurora study for cytomegalovirus (CMV) infection in hematopoietic stem cell transplant recipients. The multicenter, randomized, double-blind, double-dummy, active-controlled study was to form the basis for a future label expansion for the therapy.
Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, failed to meet the primary endpoint of noninferiority compared to Roche Holding AG’s valganciclovir in the phase III Aurora study for cytomegalovirus (CMV) infection in hematopoietic stem cell transplant recipients. The multicenter, randomized, double-blind, double-dummy, active-controlled study was to form the basis for a future label expansion for the therapy.
Synklino A/S has raised €29.8 million (US$31.8 million) in a series A round to take forward SYN-002, a treatment for cytomegalovirus (CMV) infections in both donated organs and patients undergoing hematopoietic stem cell and solid organ transplants.
Hologic Inc. received FDA premarket approval for its Aptima CMV Quant assay, which enables monitoring of viral loads of transplant patients with cytomegalovirus (CMV). While CMV typically poses little risk to adults with healthy immune systems, it can cause organ rejection and death in transplant patients if untreated. The assay gained a CE mark in June 2021.
Following an FDA priority review, Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, has won U.S. approval as the first drug in the country to treat resistant cytomegalovirus (CMV) infection and disease in adult and pediatric transplant recipients. The drug will be marketed as Livtencity.
Following an FDA priority review, Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, has won U.S. approval as the first drug in the country to treat resistant cytomegalovirus (CMV) infection and disease in adult and pediatric transplant recipients. The drug will be marketed as Livtencity.
If the FDA follows the advice of its Antimicrobial Drugs Advisory Committee, Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, will become the first drug approved in the U.S. to treat resistant or refractory cytomegalovirus infection and disease in both solid organ and hematopoietic stem cell transplant recipients. The committee voted 17-0 that the overall benefit-risk assessment favors the use of maribavir for transplant patients with refractory CMV infections both with and without genotypic resistance to the four antivirals currently used off-label to treat the infections – ganciclovir, valganciclovir, foscarnet and cidofovir.
Takeda Pharmaceutical Co. Ltd. said findings from its phase III Solstice study testing oral antiviral TAK-620 (maribavir) in treating solid organ transplant recipients with cytomegalovirus infections resistant or refractory to prior therapy (R/R CMV), showed twice the rate of confirmed CMV viremia clearance compared to other conventional therapies.
Takeda Pharmaceutical Co. Ltd. said findings from its phase III Solstice study testing oral antiviral TAK-620 (maribavir) in treating solid organ transplant recipients with cytomegalovirus infections resistant or refractory to prior therapy (R/R CMV), showed twice the rate of confirmed CMV viremia clearance compared to other conventional therapies.
DUBLIN – Spybiotech Ltd. raised $32.5 million to move into clinical trials its first in-house vaccine program based on its Spycatcher/Spytag protein conjugation technology. The company is gearing up to start a phase I trial of a vaccine directed against cytomegalovirus (CMV) early next year.
