FDA Advisory Committee Recommends Maribavir to Treat Cytomegalovirus CMV Infection and Disease

If the FDA approves maribavir, it will be the first and only treatment for adults with CMV as a result of a hematopoietic stem cell transplant or solid organ transplant.

Last night, the US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted to unanimously recommend maribavir (TAK-620) to treat refractory cytomegalovirus (CMV) infection and disease.

AMDAC approved maribavir for treating CMV infection and disease for transplant recipients both with and without genotypic resistance to ganciclovir, valganciclovir, foscarnet, and cidofovir. These recommendations were based on the positive results of the phase 2 and 3 TAK-620-303 (SOLSTICE) trials.

Maribavir, developed by Takeda Pharmaceutical Company Limited, is an orally bioavailable anti-CMV compound. It is currently the only antiviral drug in phase 3 development for treating adult post-transplant patients with CMV in hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).

In making the decision to recommend maribavir for approval, the AMDAC also heard from CMV patients, advocates, and healthcare professionals in a public forum discussion. According to Dr. Emily Blumberg, the Director of Transplant Infectious Diseases at Penn Medicine, ““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.”

Among the estimated 200000 adult transplant recipients per year globally, CMV is one of the most common viral infections, affecting 16-56% of SOT recipients and 30-70% of HSCT recipients. If approved, maribavir will be the first treatment for this patient population.

“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,” said Obi Umeh, MD, Takeda Vice President and Maribavir Global Program Leader.

Maribavir is currently under Priority Review for a New Drug Application (NDA), and the FDA will consider the affirmative AMDAC vote during the review.