Takeda’s LIVTENCITY (maribavir) Now Available for Certain Individuals Ages 12 Years and Older With Post-Transplant Cytomegalovirus (CMV) Infection/Disease in the United States

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the United States commercial availability of LIVTENCITY (maribavir), the first and only treatment for adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.¹ LIVTENCITY, an orally bioavailable anti-CMV compound, became available for prescription on December 2, 2021, just over a week after the U.S. Food and Drug Administration (FDA) approval which took place on November 23, 2021.

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“Those undergoing a life-saving transplant often have an incredibly complex medical journey to overcome, so when faced with the subsequent impact of a difficult-to-manage infection/disease such as CMV, it was a priority for our teams to expedite access to this additional treatment option,” said Cheryl Schwartz, Senior Vice President and U.S. Business Unit Lead, Rare Diseases, Takeda.

LIVTENCITY is now available to healthcare providers through a network of specialty pharmacies and distributors. For appropriate patients, physicians can submit a prescription and initiate access to treatment through a specialty pharmacy by visiting www.takedapatientsupport.com or by calling Takeda Patient Support at 1-855-268-1825. Requests for acquisition through a distributor for inpatient administration can be fulfilled by emailing [e-mail].

“Treatment of post-transplant CMV has historically been a challenge for clinicians, given that conventional antivirals have been the only treatment option,” said Emily Blumberg Director, Transplant Infectious Diseases, Penn Medicine. “The availability of LIVTENCITY, the first and only FDA-approved oral treatment for post-transplant resistant/refractory CMV, represents a significant step forward for the transplant community in addressing this difficult to treat infection/disease.”

LIVTENCITY is a new molecular entity which targets CMV at UL97, resulting in inhibition of viral DNA replication, encapsidation, and nuclear egress.^1,2,3,4,5,6 Though a rare disease overall, CMV is one of the most common infections experienced by transplant recipients, with an estimated incidence rate of around 16%–56% in solid organ transplant (SOT) recipients⁷ and 30%–70% in hematopoietic stem cell (HSCT) transplant recipients.⁸ CMV can be acquired or reactivated following transplant leading to serious consequences—including loss of the transplanted organ and failure of the graft—or loss of life. In patients with compromised immunity, CMV causes clinically challenging complications that can be fatal.^9,10,11