Takeda's Antiviral Maribavir Receives Unanimous Support from FDA Advisory Committee for Refractory CMV Infections in Transplant Patients
Takeda
Biopharmaceutical Manufacturer
FDA
U.S. Food and Drug Administration
On October 8, 2021, Takeda announced that the U.S. FDA Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously in favor of its investigational drug maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection in adult patients following hematopoietic stem cell transplantation (HSCT) or solid organ transplantation (SOT). The press release noted that, if approved by the FDA, maribavir would become the first approved therapy for this patient population.
CMV is a betaherpesvirus capable of infecting humans and is one of the most common infections in transplant recipients, with an estimated incidence of approximately 16–56% in solid organ transplant recipients and 30–70% in hematopoietic stem cell transplant recipients. It increases morbidity in patients undergoing transplantation and may also elevate the risk of graft rejection and opportunistic co-infections. Currently approved therapies not only exhibit severe adverse effects, but CMV has also developed resistance to them.
Maribavir is a UL97 protein kinase inhibitor featuring a novel mechanism of action that inhibits CMV replication, offering an improved safety profile compared to existing therapies. The US FDA previously granted Maribavir Breakthrough Therapy Designation for the treatment of CMV infection and disease in transplant patients refractory or resistant to prior therapies. In May this year, the FDA granted Maribavir Priority Review designation.
References:
[1] FDA Advisory Committee Recommends Use of Investigational Drug Maribavir (TAK-620) to Treat Post-Transplant Recipients with Cytomegalovirus (CMV) Infection and Disease Refractory to Treatment With or Without Resistance. Retrieved October 8, 2021, from https://www.businesswire.com/news/home/20211007006064/en/FDA-Advisory-Committee-Recommends-Use-of-Investigational-Drug-Maribavir-TAK-620-to-Treat-Post-Transplant-Recipients-with-Cytomegalovirus-CMV-Infection-and-Disease-Refractory-to-Treatment-With-or-Without-Resistance
*Disclaimer: This article was written by a contributor to Sina Pharmaceutical News. The views expressed are solely those of the author and do not represent the position of Sina Pharmaceutical News.▽Follow 【WuXi AppTecGermany】WeChat Official Account
