- Transplant patients in the U.S. with a common infection now have a new treatment option, with this week's approval of Takeda Pharmaceutical's maribavir, which will be sold in the U.S. as Livtencity.
- The Food and Drug Administration on Tuesday cleared the medicine for patients with a cytomegalovirus, or CMV, infection that's resistant to other available antiviral treatments. To date, those patients haven't had a fallback treatment option after older drugs stop working.
- Livtencity will be available within days in the U.S., Takeda said. The company is seeking regulatory approvals around the world and is also testing the drug as an initial treatment, including in a Phase 3 study of patients who have CMV following a hematopoietic stem cell transplant.
Livtencity is part of the first wave of new products Takeda hopes will reposition the company as a top player in the pharmaceutical industry for years to come. Earlier this year, the Japanese drugmaker won approval for a targeted lung cancer drug.
The FDA says Takeda's CMV treatment will address "a significant unmet medical need" among transplant patients. CMV infections are very common in that group, and the disease can cause complications ranging from loss of the transplanted organ to death.
Transplant patients are particularly vulnerable to infection because they must take drugs to stop their immune systems from attacking the new tissue, cells or organs implanted in their body. These immunosuppressive drugs are critical to preserving the transplant, but they can also leave a patient vulnerable to other diseases.
Patients who need treatment for CMV have generally been given one or more of a group of antiviral drugs: ganciclovir, valganciclovir, foscarnet or cidofovir. When those fail, the outlook for patients is much worse.
Livtencity works differently than those other antivirals, disrupting the virus at three different points in its life cycle. That means the medicine can work on infections resistant to older drugs, according to Takeda. The company's research showed Livtencity could depress the virus to unmeasurable levels in 56% of patients, compared with 24% of people receiving traditional treatment.
Side effects to treatment commonly included changes in taste, nausea, diarrhea and fatigue. Livtencity may reduce the effectiveness of ganciclovir and valganciclovir, the FDA said, so co-administration with those drugs is not recommended.
Other drugmakers are working on ways to prevent CMV infections altogether. Moderna, for instance, is developing a vaccine that has shown promise in early research. The virus is also common in the general population; more than half of adults have been infected by the age of 40, often without symptoms, according to the Centers for Disease Control and Prevention.