Is maribavir FDA approved?

Today, the U.S. Food and Drug Administration approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients (12 years of age and older and weighing at least 35 kilograms) with post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations …

Can maribavir be crushed?

Crushing MBV tablets is a viable option for administration of MBV to patients who are unable to swallow whole tablets.

What is refractory CMV?

Refractory or resistant cytomegalovirus (CMV) infections are challenging complications after hematopoietic cell transplantation (HCT). Most refractory or resistant CMV infections are associated with poor outcomes and increased mortality.

What is maribavir used for?

This medication is used to treat cytomegalovirus (CMV) disease or infection in people who have received a transplant. Maribavir is an anti-viral drug. It works by stopping the growth of the virus.

What is Cytomegalovirus CMV infection?

Cytomegalovirus infection is a common herpesvirus infection with a wide range of symptoms: from no symptoms to fever and fatigue (resembling infectious mononucleosis) to severe symptoms involving the eyes, brain, or other internal organs. This virus. It requires a living cell in which to multiply.

Does acyclovir cover CMV?

Acyclovir has less activity against cytomegalovirus in vitro because it lacks a virus–specific thymidine kinase needed for initial phosphorylation. However, acyclovir triphosphate is a potent inhibitor of cytomegalovirus DNA polymerase in vitro.

How do you treat CMV resistant?

Four antiviral drugs are used for preventing or treating CMV: ganciclovir, valganciclovir, foscarnet, and cidofovir. With prolonged and repeated use of these drugs, CMV can become resistant to standard therapy, resulting in increased morbidity and mortality, especially in HCT recipients.

What are refractory infections?

(reh-FRAK-tor-ee) In medicine, describes a disease or condition that does not respond to treatment.

What is foscarnet used to treat?

Foscarnet is principally used for the treatment of ganciclovir-resistant cytomegalovirus (CMV) infections in patients with the acquired immunodeficiency syndrome (AIDS) or in transplant recipients.

What is livtencity (maribavir)?

^ a b c “Takeda’s Livtencity (maribavir) Approved by U.S. FDA as the First and Only Treatment for People Ages 12 and Older with Post-Transplant Cytomegalovirus (CMV), Refractory (With or Without Genotypic Resistance) to Conventional Antiviral Therapies”. Takeda (Press release). 23 November 2021.

Maribavir is a cytomegalovirus pUL97 kinase inhibitor that works by preventing the activity of human cytomegalovirus enzyme pUL97, thus blocking virus replication. Maribavir was approved for medical use in the United States in November 2021.

Is maribavir effective for preemptive treatment of cytomegalovirus infection in transplant recipients?

Jingyang Wu, M.S., Maribavir is a benzimidazole riboside with activity against cytomegalovirus (CMV). The safety and efficacy of maribavir for preemptive treatment of CMV infection in transplant recipients is not known.

How many milligrams of maribavir will I receive in a clinical trial?

Participants will receive 400 milligrams (mg) of maribavir (2*200 mg tablets) twice daily (BID) orally along with a placebo matched to valganciclovir for 8 weeks. Participants will receive 400 mg of maribavir BID orally. Participants will receive placebo tablets matched to either maribavir or valganciclovir.