Takeda (TAK) Announces EC Approval of LIVTENCITYTM

Takeda (NYSE: TAK) today announced that the European Commission (EC) has granted Marketing Authorization for LIVTENCITYTM (maribavir) for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet, in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).4 LIVTENCITY is the first and only oral treatment that inhibits CMV-specific UL97 protein kinase and its natural substrates.1

CMV is one of the most common infections experienced by transplant patients with a global estimated incidence rate of 16-56% in SOT and 30-80% in HSCT recipients.5,6 More than 34,000 SOTs,7 including liver, kidney, and heart transplant, and more than 48,000 HSCTs8 were performed in Europe and neighboring countries in 2019. Although prevention and management of CMV infection in SOT and HSCT patients with available therapies may help improve outcomes,5 breakthrough infections can still occur with prophylaxis,9 and some CMV infections may not respond to treatment.10

“The European Society for Organ Transplantation (ESOT) understands that the transplant patient journey extends well beyond the transplant itself. When not successfully treated, CMV poses a challenge to transplant recipients and their physicians and often leads to increased organ rejection, higher hospitalization rates, and greater burden on healthcare resources, contributing to inequities for patients across the system,” said Dr. Luciano Potena, ESOT President. “The approval of LIVTENCITY by the EC recognizes the need for a new antiviral approach for managing CMV infection that is refractory (with or without resistance) to one or more prior CMV therapies.”

The centralized marketing authorization is valid in all EU member states as well as in Iceland, Liechtenstein, Norway, and Northern Ireland, and was based on the Phase 3 SOLSTICE trial, which evaluated the safety and efficacy of LIVTENCITY versus conventional antiviral therapies—ganciclovir, valganciclovir, cidofovir or foscarnet—for the treatment of adult HSCT and SOT recipients with CMV infection refractory (with or without resistance) to prior therapies.

The EC approval marks the fourth approval of LIVTENCITY for post-transplant refractory (with or without resistance) CMV infection, following the U.S., Canada, and Australia.13-15

“Patients who receive a transplant can face a difficult journey on the road to recovery that involves medicines to suppress their immune system. The additional burden of a CMV infection that has become refractory to treatment, and which could threaten their transplant, poses a challenge to patients being offered a second chance at life,” said Ramona Sequeira, President, Global Portfolio Division, Takeda. “With the EC approval of LIVTENCITY, we are privileged to offer healthcare providers in the EU and EEA* with an additional oral antiviral treatment for post-transplant refractory CMV.”

About CMV

CMV is a beta herpesvirus that commonly infects humans; serologic evidence of prior infection can be found in 40-100% of various adult populations.14 CMV typically resides latent and asymptomatic in the body but may reactivate during periods of immunosuppression. Serious disease may occur in individuals with compromised immune systems, which includes patients who receive immunosuppressants associated with various types of transplants including HSCT or SOT.5 Out of the estimated 200,000 adult transplants per year globally, CMV is one of the most common viral infections experienced by transplant recipients, with an estimated incidence rate between 16-56% in SOT recipients and 30-80% in HSCT recipients.5,6

In transplant recipients, reactivation of CMV can lead to serious consequences including loss of the transplanted organ and, in extreme cases, can be fatal.2,3 Existing therapies to treat post-transplant CMV infections may demonstrate serious side effects that require dose adjustments or may fail to adequately suppress viral replication.10 Additionally, existing therapies may require or prolong hospitalization due to administration.

You May Also Be Interested In

• Allarity Therapeutics files SPAC registration for $100M IPO
• Glucotrack secures $11.5M in convertible note financing
• Spectral Medical gets FDA feedback on PMX device application