Recently, the US FDA has approved Takeda Livtencity (maribavir) to treat patients with cytomegalovirus (CMV) infection after transplantation in adults or children 12 years of age or older. According to Takeda’s estimates, there are about 200,000 adult transplant operations worldwide each year, and about a quarter of all transplant patients may be infected with cytomegalovirus. Therefore, based on this data, Takeda predicts that Livtencity’s peak sales may reach 7 100 million to 800 million US dollars.

In a phase 3 trial, compared with the conventional antiviral treatment selected by doctors, the proportion of patients with undetectable CMV DNA in the blood after 8 weeks of Livtencity treatment more than doubled. The results of the trial showed that a total of 55.7% Livtencity users achieved confirmed CMV viremia clearance, compared to only 23.9% in the control group. All subjects in the study had previously received one or more existing CMV drugs (such as ganciclovir, valganciclovir, foscarnet, or cidofovir), but none of them were successful .

Livtencity has similar efficacy between solid organ transplants and hematopoietic cell transplants. Although the researchers limited the treatment to 8 weeks, 18.7% of patients in Livtencity still maintained CMV viremia clearance and symptom control in the 16th week, while only 10.3% of patients in traditional therapy achieved this result. It is worth mentioning that Livtencity is the first and only drug approved by the US FDA for the treatment of CMV infection after transplantation that is refractory to conventional antiviral therapy (with or without genotype resistance).

Livtencity was approved through the priority review process and has previously been granted Orphan Drug Designation (ODD) and Breakthrough Drug Designation (BTD) by the FDA. Livtencity adopts a new mechanism of action. The active pharmaceutical ingredient of Livtencity is maribavir, which is an oral bioavailable anti-cytomegalovirus (CMV) compound, and is the only one that targets and inhibits pUL97 protein kinase and its CMV antiviral drugs with natural substrates.

Another part of Livtencity's market opportunity lies in its potential to enter the first-line treatment of CMV infection after transplantation. An ongoing Phase 3 study is comparing the efficacy of Takeda's drug with Roche's Valcyte in stem cell transplant patients. Takeda expects to approve this indication by March 2024. The approval of Livtencity also marks the second approval for Takeda's Wave1 product line pipeline, which also includes more than a dozen drugs and vaccines that the company hopes to launch by fiscal 2024. In September of this year, Exkivity received conditional approval from the US FDA for the previous treatment of non-small cell lung cancer with EGFR exon 20 insertion mutations.

Takeda’s next major regulatory milestone may come from the dengue vaccine candidate TAK-003. The company now expects that the vaccine may be approved in the European Union in 2022 after the European Medicines Agency's drug regulatory agency recently converted the accelerated review of the therapy to a normal evaluation.