Ganciclovir

Takeda Announces China NMPA Approval of LIVTENCITY® (maribavir) for the Treatment of Adults With Post-transplant Cytomegalovirus (CMV) Refractory to Prior Therapies

Retrieved on: 
Thursday, December 21, 2023
Infectious Diseases, Biotechnology, Pharmaceutical, Health, Transplant, SOT, CDE, CMV, Cidofovir, Incidence, Hospital, Week, NMPA, Ganciclovir, Infection, European, National Medical Products Administration, Cytomegalovirus, Valganciclovir, Patient, Safety, Foscarnet

Takeda ( TSE:4502/NYSE:TAK ) today announced that LIVTENCITY® (maribavir) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that LIVTENCITY® (maribavir) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.
  • LIVTENCITY is the first and only inhibitor of CMV-specific UL97 protein kinase in China for this indication.
  • LIVTENCITY was granted Breakthrough Therapy Designation by China Center for Drug Evaluation (CDE) in 2021.
  • “This approval will help redefine the CMV treatment landscape for transplant patients in China and is a positive step forward toward addressing an unmet need for this community.”
    The NMPA approval is based on the results of the Phase 3 SOLSTICE trial, which evaluated the safety and efficacy of maribavir versus conventional antiviral therapies – ganciclovir, valganciclovir, cidofovir or foscarnet – for the treatment of patients with CMV infection/disease refractory* to prior therapies.

European Commission (EC) Approves LIVTENCITYTM▼ (maribavir) for the Treatment of Adults With Post-transplant Cytomegalovirus (CMV) Infection And/or Disease That Are Refractory (With or Without Resistance) to One or More Prior Therapies

Retrieved on: 
Friday, November 11, 2022
Research, Surgery, Infectious Diseases, Clinical Trials, Stem Cells, Other Health, Biotechnology, Pharmaceutical, Health, Science, Foscarnet, Transplant, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Degenerative disease, Hospital, Organ transplantation, EEA, Food, Incidence, SOT, CMV, Valganciclovir, Disease, Plasma protein binding, Ganciclovir, EudraCT, Life, Adult, Tablet, Middle East Society for Organ Transplantation, Health Canada, Patient, Cytomegalovirus, Immunosuppression, Infection, Immune system, Safety, TAK, European Commission, Royal commission, EC, Liver, Kidney, Human, Cidofovir, Physician, Dentistry, Pharmaceutical industry, Dietary supplement, Takeda, HSCT, EU

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.

Key Points: 
  • 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.
  • CMV DNA levels should be monitored and resistance mutations should be investigated in patients who do not respond to treatment.
  • Serum digoxin concentrations should be monitored, and dose of digoxin may need to be reduced, as needed (see Table 1).
  • Co-administration of maribavir with sensitive BCRP substrates such as rosuvastatin, is expected to increase their exposure and lead to undesirable effects.

Takeda Receives Positive CHMP Opinion for Maribavir for the Treatment of Adults with Post-transplant Cytomegalovirus (CMV) Refractory (With or Without Resistance) to Prior Therapies

Retrieved on: 
Friday, September 16, 2022
Science, Stem Cells, Biotechnology, Research, Pharmaceutical, Health, Infectious Diseases, Clinical Trials, Adult, Hospital, Maribavir, Degenerative disease, Safety, Committee for Medicinal Products for Human Use, Infection, Incidence, Human, Transplant, EudraCT, FDA, Food, Cidofovir, European Commission, Ganciclovir, Patient, Head, Foscarnet, SOT, European Medicines Agency, Valganciclovir, TAK, CHMP, EC, Committee, Cytomegalovirus, Marketing, Union, Food and Drug Administration, EMA, Disease, CMV, Immunosuppression, Dentistry, Pharmaceutical industry, HSCT, EU, Takeda

The European Commission (EC) will consider the CHMP positive opinion and decide upon potential marketing authorization in the coming months.

Key Points: 
  • The European Commission (EC) will consider the CHMP positive opinion and decide upon potential marketing authorization in the coming months.
  • Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI).
  • In this press release, Takeda is sometimes used for convenience where references are made to Takeda and its subsidiaries in general.
  • Maribavir for refractory cytomegalovirus infections with or without resistance post-transplant: results from a phase 3 randomized clinical trial.

Takeda Presents New Exploratory Analysis Showing Patients Treated With LIVTENCITY™ (Maribavir) Had Reductions in Hospitalization Rates and Length of Hospital Stay

Retrieved on: 
Friday, April 22, 2022
Health, Infectious Diseases, Surgery, Clinical Trials, Pharmaceutical, Biotechnology, Cytomegalovirus, Duke University School of Medicine, SOT, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, TAK, MD, Food, Incidence, European, Infection, Patient, Valganciclovir, CMV, Ganciclovir, 2021 Essex County Council election, Pathology, FDA, Foscarnet, Congress, Pharmaceutical industry, Dentistry, HSCT, Takeda

During the treatment phase, 31.9% of patients treated with LIVTENCITY (n=75/235) had at least one hospitalization compared to 36.8% of patients treated with conventional therapies (n=43/117).

Key Points: 
  • During the treatment phase, 31.9% of patients treated with LIVTENCITY (n=75/235) had at least one hospitalization compared to 36.8% of patients treated with conventional therapies (n=43/117).
  • The length of hospital stay during the treatment phase (adjusting for time on treatment) was 13.27 days/person/year in LIVTENCITY-treated patients compared to 28.73 for those conventionally treated, a 53.8% decrease (p=0.029).
  • Consider the potential for drug interactions prior to and during LIVTENCITY therapy; review concomitant medications during LIVTENCITY therapy and monitor for adverse reactions.
  • The most common adverse events (all grades,> 10%) in subjects treated with LIVTENCITY were taste disturbance, nausea, diarrhea, vomiting, and fatigue.

Amber Specialty Pharmacy Selected by Takeda to Dispense LIVTENCITY™ (maribavir) for the Treatment of Adults and Pediatric Patients with Post-Transplant CMV Infection/Disease that is Refractory to Treatment

Retrieved on: 
Friday, December 3, 2021
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Through this partnership, Amber Specialty Pharmacy's best-in-class service model will support transplant facilities and patients throughout the country.

Key Points: 
  • Through this partnership, Amber Specialty Pharmacy's best-in-class service model will support transplant facilities and patients throughout the country.
  • Amber Specialty Pharmacy was established in 1998 as the first specialty pharmacy to focus on the life-long health and needs of the transplant community.
  • Amber Specialty Pharmacy has built an exceptional reputation by providing personalized support and quality clinical care to patients and families.
  • Amber Specialty Pharmacy was named the 2020 Specialty Pharmacy of the Year by the National Association of Specialty Pharmacy.

Takeda’s LIVTENCITYTM (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

Retrieved on: 
Tuesday, November 23, 2021
Health, FDA, Infectious Diseases, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Patient, FDA, Takeda Pharmaceutical Company, Regulation of tobacco by the U.S. Food and Drug Administration, TAK, Ganciclovir, Cidofovir, Adult, CMV, Valganciclovir, Food, Dentistry, Takeda, CMV, LIVTENCITY, Takeda Pharmaceutical Company Limited, TAKEDA, CMV, LIVTENCITY, TAKEDA PHARMACEUTICAL COMPANY LIMITED

For appropriate patients, physicians can submit a prescription to initiate access to treatment by contacting Takeda Patient Support at 1-855-268-1825.

Key Points: 
  • For appropriate patients, physicians can submit a prescription to initiate access to treatment by contacting Takeda Patient Support at 1-855-268-1825.
  • In clinical studies, we observed LIVTENCITY was statistically superior to conventional antiviral therapies in achieving the primary endpoint at Week 8.
  • Takeda Patient Support is available to help patients prescribed LIVTENCITY gain access to their medication, find educational resources, and understand financial assistance options.
  • Monitor CMV DNA levels and check for maribavir resistance if the patient is not responding to treatment or relapses.

FDA Approves First Treatment for Common Type of Post-Transplant Infection that is Resistant to Other Drugs

Retrieved on: 
Tuesday, November 23, 2021
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"Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern.

Key Points: 
  • "Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern.
  • Today's approval helps meet a significant unmet medical need by providing a treatment option for this patient population."
  • CMV is a type of herpes virus that commonly causes infection in patients after a stem cell or organ transplant.
  • CMV infection can lead to CMV disease and have a major negative impact on transplant recipients, including loss of the transplanted organ and death.

 U.S. Food & Drug Administration Grants Priority Review of Maribavir for the Treatment of Post-Transplant Recipients With Cytomegalovirus Infection in Those Resistant and/or Refractory to Prior Anti-CMV Treatment

Retrieved on: 
Friday, May 21, 2021
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Organic compounds, Chemical compounds, Virology, Betaherpesvirinae, Human betaherpesvirus 5, Maribavir, Breakthrough therapy, Ganciclovir, Valganciclovir

The FDA has also granted maribavir Breakthrough Therapy Designation as a treatment for CMV infection and disease in transplant patients resistant or refractory to prior therapy.

Key Points: 
  • The FDA has also granted maribavir Breakthrough Therapy Designation as a treatment for CMV infection and disease in transplant patients resistant or refractory to prior therapy.
  • Orphan status is granted to certain investigational medicines intended for the treatment or prevention of a rare, life-threatening disease.
  • The FDA has also granted maribavir Breakthrough Therapy Designation as a treatment for CMV infection and disease in transplant patients resistant or refractory to prior therapy.
  • Function of human cytomegalovirus UL97 kinase in viral infection and its inhibition by maribavir: Human cytomegalovirus UL97 kinase.

New Phase 3 Data Show TAK-620 (maribavir), an Investigational Drug for the Treatment of Transplant Recipients with Refractory/Resistant Cytomegalovirus (CMV) Infections, Meets Primary Endpoint

Retrieved on: 
Friday, December 4, 2020
Health, Infectious diseases, Other Health, Clinical trials, Pharmaceutical, Biotechnology, Medical specialties, Health sciences, Clinical medicine, Benzimidazoles, Chloroarenes, Maribavir, Nucleosides, Transplantation medicine, Breakthrough therapy, Human betaherpesvirus 5, Ganciclovir, CMV, Maribavir, Takeda’s Maribavir Phase 2 Study

Orphan status is granted to certain investigational medicines intended for the treatment or prevention of a rare, life-threatening disease.

Key Points: 
  • Orphan status is granted to certain investigational medicines intended for the treatment or prevention of a rare, life-threatening disease.
  • The FDA has also granted maribavir Breakthrough Therapy Designation as a treatment for CMV infection and disease in transplant patients resistant or refractory to prior therapy.
  • Clinical impact of neutropenia related with the preemptive therapy of CMV infection in solid organ transplant recipients.
  • Maribavir for refractory or resistant cytomegalovirus infections in hematopoietic-cell or solid-organ transplant recipients: a randomized, dose-ranging, double-blind, phase 2 study.

New England Journal of Medicine Publishes Results of a Phase 2 Trial Evaluating Takeda’s TAK-620 (Maribavir) as a Potential Treatment of Cytomegalovirus (CMV) Infection

Retrieved on: 
Tuesday, September 24, 2019
Science, Biotechnology, Pharmaceutical, Research, Health, Clinical trials, Organic compounds, Chemistry, Chemical compounds, Genentech, Ethers, Purines, RTT, Diols, Ganciclovir, Valganciclovir, Maribavir, Human betaherpesvirus 5

In the study, most TEAEs with maribavir (58%) were considered mild to moderate in severity versus 42.5% for valganciclovir.

Key Points: 
  • In the study, most TEAEs with maribavir (58%) were considered mild to moderate in severity versus 42.5% for valganciclovir.
  • In line with earlier reported results, maribavir was associated with an increased incidence of gastrointestinal adverse events compared with valganciclovir (20-23% vs. 10-15%).
  • These results are encouraging and warrant further investigation of maribavir as a potentially effective and tolerated treatment for CMV in transplant patients.
  • The two randomised Phase 3 trials evaluating maribavir for the treatment of CMV infection in transplant patients are currently enrolling patients.