Transplant patients who experience a potentially deadly viral infection that doesn’t respond to existing treatments have a new FDA-approved treatment option. For the therapy’s developer, Takeda, the approval adds another component to its growth plans in the years to come.
The FDA has greenlighted Takeda’s Livtencity, or maribavir, for patients 12 years of age or older with post-transplant cytomegalovirus (CMV) infection that’s refractory to one of four existing drugs, the company said Wednesday.
About 200,000 adult transplants take place each year globally, and, among all transplant recipients, about a quarter could experience CMV infections, by Takeda’s estimate. Based on those figures, the Japanese pharma has projected $700 million to $800 million in peak sales for Livtencity.
In a phase 3 trial, Livtencity more than doubled the proportion of patients who experienced confirmed undetectable blood CMV DNA compared with physician’s choice of conventional antiviral therapy after eight weeks of treatment. Altogether, 55.7% of Livtencity takers achieved confirmed CMV viremia clearance, versus 23.9% for control.
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All the transplant recipients in the study had previously been treated with—but failed on—one or a combination of existing CMV drugs ganciclovir, valganciclovir, foscarnet or cidofovir. Livtencity’s efficacy was similar between recipients of solid organ transplant and hematopoietic cell transplant.
While investigators capped treatment at eight weeks, 18.7% of patients on Livtencity maintained CMV viremia clearance and symptom control through Week 16, whereas just 10.3% of those on conventional therapies could say that.
Livtencity brings a new mechanism of action, targeting CMV at pUL97 to inhibit several critical steps in the virus’s life cycle, including viral DNA replication.
Another part of Livtencity’s market opportunity lies in its potential to move into front-line treatment for post-transplant CMV infection. An ongoing phase 3 study is pitting the Takeda drug against Roche’s Valcyte in stem cell transplant patients. Takeda expects a potential approval for that indication by March 2024.
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Livtencity marks the second approval from Takeda’s Wave 1 pipeline, which includes about a dozen drugs and vaccines the company hopes to roll out by fiscal year 2024. The company in September won a conditional FDA approval for Exkivity in previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations.
The next major regulatory milestone for Takeda could come from dengue vaccine candidate TAK-003. The company now expects a potential EU approval in 2022 after drug regulators at the European Medicines Agency recently converted an accelerated review into a normal evaluation.