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

  • If Approved, Maribavir Would be the First and Only Inhibitor of CMV-specific UL97 Protein Kinase in the EU for Treatment of Adults with Post-transplant CMV Refractory (With or Without Resistance) to Prior Therapies1
  • Positive Opinion Based on Phase 3 SOLSTICE Study Demonstrating Maribavir Was Statistically Superior to Conventional Therapies at Study Week 8, for Primary Endpoint2
  • CMV is One of the Most Common and Serious Post-transplant Infections and Can Lead to Loss of Transplanted Organ and Failure of Graft 3,4

Takeda( TSE4502/ NYSETAK) moment blazoned the European Medicines Agency’s( EMA) Committee for Medicinal Products for Human Use( CHMP) has recommended the blessing of maribavir for the treatment of cytomegalovirus( CMV) infection and/ or complaint that are refractory( with or without resistance) to one or further previous curatives, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult cases who have experienced a hematopoietic stem cell transplant( HSCT) or solid organ transplant( SOT).

The European Commission( EC) will consider the CHMP positive opinion and decide upon implicit marketing authorization in the comingmonths.However, maribavir would be the first asset of CMV-specific UL97 protein kinase in the European Union( EU) for this suggestion, If approved.1 The positive opinion from the CHMP was grounded on the SOLSTICE trial, which estimated the safety and efficacity of maribavir versus conventional antiviral curatives — ganciclovir, valganciclovir, foscarnet or cidofovir — for the treatment of cases with CMV infection refractory, with or without resistance.
“Post-transplant care is critical for transplant donors, and CMV infection can peril successful issues for cases, ” said Daniel Curran, Head, Rare conditions Therapeutic Area, Takeda. “ The CHMP positive opinion on the marketing authorization of maribavir is a positive step toward reconsidering the CMV treatment geography for transplant cases and their healthcare providers across Europe and toward addressing a great unmet need for this community. ”

CMV is one of the most common infections endured by transplant cases, with a global estimated prevalence rate of 16 – 56 in SOT donors and 30 – 70 in HSCT donors.5, 6 further than,000 SOTs7 and further than,000 HSCTs8 were performed in Europe and bordering countries in 2019.

About CMV
CMV is a beta herpesvirus that generally infects humans; serologic substantiation of previous infection can be set up in 40- 100 of colorful adult populations.9 CMV generally resides idle and asymptomatic in the body but may extinguish during ages of immunosuppression. Serious complaint may do in individualities with compromised vulnerable systems, which includes cases who admit immunosuppressants associated with colorful types of transplants including HSCT orSOT.5 Out of the estimated,000 adult transplants per time encyclopedically, CMV is one of the most common viral infections endured by transplant donors, with an estimated prevalence rate between 16- 56 in SOT donors and 30- 70 in HSCT donors.5, 6
In transplant donors, reactivation of CMV can lead to serious consequences including loss of the transplanted organ and, in extreme cases, can be fatal.3, 4 Being curatives to treatpost-transplant CMV infections may demonstrate serious side goods that bear cure adaptations or may fail to adequately suppress viral replication.10 also, being curatives may bear or protract hospitalization due to administration.10, 11

About Maribavir
Maribavir, an orally bioavailableanti-CMV emulsion, is the first and only antiviral agent that targets and inhibits the pUL97 protein kinase and its natural substrates.1

In November 2021, maribavir enteredU.S. Food and Drug Administration( FDA) blessing, under the brand name LIVTENCITYTM, for the treatment of grown-ups and pediatric cases( 12 times of age or aged and importing at least 35 kg) withpost-transplant cytomegalovirus( CMV) infection/ complaint that’s refractory to treatment( with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir, or foscarnet. In addition to awaiting a final European Commission decision, nonsupervisory forms are underway with other health authorities worldwide.

About Takeda’s SOLSTICE Trial
The TAK-620-303( SOLSTICE) trial( NCT02931539, EudraCT 2015-004725-13) was a global, multicenter, randomized, open- marker, active- controlled superiority trial to assess the efficacity and safety of treatment with either maribavir or conventional antiviral remedy in 352 hematopoietic stem cell transplant and solid organ transplant donors with CMV infection refractory, with or without resistance, to one or a combination of the conventional antiviral curatives ganciclovir, valganciclovir, foscarnet or cidofovir. Adult cases passed a 2- week webbing period, followed by randomization 21 to maribavir( n = 235)( 400 mg, doubly daily) or conventional antiviral curatives( n = 117)( as cured by the investigator) for over to 8- weeks. After completion of the treatment period, subjects entered a 12- week follow- up phase.2
The trial’s primary efficacity endpoint was verified CMV DNA position< LLOQ( lower limit of quantification,( i.e.< 137 IU/ mL) in 2 successive samples separated by at least 5 days as assessed by COBAS ® AmpliPrep/ COBAS ® TaqMan ® CMV test) at the end of Week 8. The crucial secondary endpoint was CMV DNA position< LLOQ and CMV infection symptom control * at the end of Study Week 8 with conservation of this treatment effect through Study Week16.2

About Takeda
Takeda is a global, values- grounded, R&D- driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life- transubstantiating treatments, guided by our commitment to cases, our people and the earth. Takeda focuses its R&D sweats on four remedial areas Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology( GI). We also make targeted R&D investments in Tube- deduced curatives and Vaccines. We’re fastening on developing largely innovative drugs that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and using our enhanced cooperative R&D machine and capabilities to produce a robust, modality-different channel. Our workers are committed to perfecting quality of life for cases and to working with our mates in health care in roughly 80 countries and regions.

Source link:https://www.takeda.com/

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