Based on results from the Phase II and Phase III TAK-620-303 (SOLSTICE) trials, members of the AMDAC unanimously voted in favor of using maribavir.
Patrick Seeger/picture alliance via Getty.
The U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee (AMDAC) has unanimously voted on the use of Takeda Pharmaceutical Company’s maribavir to treat different types of refractory cytomegalovirus (CMV) infection.
Based on results from the Phase II and Phase III TAK-620-303 (SOLSTICE) trials, members of the AMDAC unanimously voted in favor of using maribavir (TAK-620) to treat refractory CMV infection and disease with genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients. They also recommend the same for the treatment of refractory CMV without genotypic resistance to the same medications.
The FDA has placed Takeda’s New Drug Application for maribavir under Priority Review, and this vote of confidence from the AMDAC will be taken into account when the regulator makes its final decision. The NDA submission is based on the Phase III study. The AMDAC also collected insights and responses from advocates, patients, and healthcare providers in a public forum.
“Today’s vote in favor of our investigational antiviral drug marks a significant step towards delivering the first approved treatment for adult transplant recipients with refractory CMV infection and disease, with or without resistance. We look forward to working with the FDA as it completes its review of our application,” said Obi Umeh, M.D, vice president and maribavir global program leader at Takeda, in a statement.
CMV is a beta herpes virus that commonly affects individuals who have compromised immune systems. Out of the approximately 200,000 adult transplants per year worldwide, CMV is one of the most common viral infections. It has an estimated incidence rate of between 16% and 56% in solid organ transplant recipients and 30% to 70% percent in hematopoietic stem cell transplant patients.
In patients who have undergone a transplant, reactivating CMV can lead to severe consequences, including the loss of the new organ and, in extreme cases, death. Existing therapies for post-transplant infections may demonstrate toxicities that require dose adjustments or may fail to suppress the replication of the virus. Other current treatments may also require prolonged hospitalization.
“The treatment of CMV in patients who have undergone a solid organ or stem cell transplant is complicated, especially in patients who have failed standard treatment and who may be at risk for side effects from currently available medications. I am excited about the potential for an additional treatment option for post-transplant patients with CMV,” noted Dr. Emily Blumberg, the director for transplant infectious diseases at Penn Medicine.
Maribavir is an orally bioavailable anti-CMB compound that is reportedly the only CMV antiviral drug that targets and inhibits the UL97 protein kinase and its natural substances. The European Commission has granted it an Orphan Drug Designation to treat CMV disease in patients diagnosed with impaired cell-mediated immunity, and by the FDA for the treatment of clinically significant CMV viremia and disease in at-risk patients. Maribavir also has a Breakthrough Therapy Designation from the FDA.
