FIC: Takeda submitted the application of new drug: Maribavir to FDA
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FIC: Takeda submitted the application of new drug: Maribavir to FDA
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FIC: Takeda submitted the application of new drug: Maribavir to FDA. Maribavir is Takeda’s fourth new molecular entity to submit a listing application in the past six months.
On May 21, Takeda announced that it had submitted Maribavir’s marketing application to the FDA to treat refractory, with or without drug resistance (R/R) transplanted cytomegalovirus (CMV). If approved, Maribavir will become the first one. The only one to treat cytomegalovirus (CMV) infection after transplantation.
The application is based on a phase III clinical trial AK-620-303 (SOLSTICE, NCT02931539), in which Maribavir is combined with conventional antiviral drugs (researcher-specified treatment [IAT], one or more of the following drugs: Ganciclovir [ganciclovir], valganciclovir [valganciclovir], foscarnet [foscarnet], cidofovir [cidofovir]) were compared.
Maribavir reached the primary endpoint in this phase III clinical trial—the CMV viremia clearance rate confirmed at the 8th week of treatment (end of the treatment period), and the key secondary endpoint—the CMV clearance rate and symptom control were maintained until week 16. Compared with conventional antiviral therapy (IAT), maribavir has superior efficacy and lower treatment-related toxicity.
In about 200,000 adult transplants (including hematopoietic cell transplantation (HCT) or solid organ transplantation (SOT), etc.) each year, CMV is one of the most common viral infections in transplant recipients. The incidence of SOT patients is 16-56%. HCT patients are 30-70%.
Maribavir is the fourth new molecular entity that Takeda has submitted for marketing in the past 6 months, and it is also the only UL97 protein kinase and its natural substrate inhibitor that has entered the phase III clinical trial of anti-CMV virus.
It has previously been granted by the FDA Treatment of refractory, with or without drug resistance (R/R) post-transplant cytomegalovirus (CMV) breakthrough therapy, enjoys priority review qualifications.
FIC: Takeda submitted the application of new drug: Maribavir to FDA
(source:internet, reference only)
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