Osaka, Japan & Cambridge, Mass., United States:
− 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(TSE:4502/NYSE:TAK) right now introduced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has beneficial the approval of maribavir for the remedy of cytomegalovirus (CMV) an infection and/or illness which might be refractory (with or with out resistance) to one or extra prior therapies, together with ganciclovir, valganciclovir, cidofovir or foscarnet in grownup sufferers who’ve undergone a hematopoietic stem cell transplant (HSCT) or stable organ transplant (SOT).
The European Commission (EC) will take into account the CHMP constructive opinion and determine upon potential advertising and marketing authorization in the coming months. If accredited, maribavir could be the first inhibitor of CMV-specific UL97 protein kinase in the European Union (EU) for this indication.1 The constructive opinion from the CHMP was primarily based on the SOLSTICE trial, which evaluated the security and efficacy of maribavir versus standard antiviral therapies—ganciclovir, valganciclovir, foscarnet or cidofovir—for the remedy of sufferers with CMV an infection refractory, with or with out resistance.
“Post-transplant care is critical for transplant recipients, and CMV infection can jeopardize successful outcomes for patients,” mentioned Daniel Curran, Head, Rare Diseases Therapeutic Area, Takeda. “The CHMP positive opinion on the marketing authorization of maribavir is a positive step toward redefining the CMV treatment landscape for transplant patients and their healthcare providers across Europe and toward addressing a great unmet need for this community.”
CMV is one of the most typical infections skilled by transplant sufferers, with a world estimated incidence price of 16%–56% in SOT recipients and 30%–70% in HSCT recipients.5,6 More than 34,000 SOTs 7 and greater than 48,000 HSCTs 8 have been carried out in Europe and neighboring international locations in 2019.
About CMV
CMV is a beta herpesvirus that generally infects people; serologic proof of prior an infection could be present in 40%-100% of varied grownup populations.9 CMV usually resides latent and asymptomatic in the physique however might reactivate in periods of immunosuppression. Serious illness might happen in people with compromised immune methods, which incorporates sufferers who obtain immunosuppressants related with varied varieties of transplants together with HSCT or SOT.5 Out of the estimated 200,000 grownup transplants per yr globally, CMV is one of the most typical viral infections skilled by transplant recipients, with an estimated incidence price between 16-56% in SOT recipients and 30-70% in HSCT recipients.5,6
In transplant recipients, reactivation of CMV can lead to critical penalties together with loss of the transplanted organ and, in excessive circumstances, could be deadly.3,4 Existing therapies to deal with post-transplant CMV infections might show critical unwanted effects that require dose changes or might fail to adequately suppress viral replication.10 Additionally, present therapies might require or delay hospitalization due to administration.10,11
About Maribavir
Maribavir, an orally bioavailable anti-CMV compound, is the first and solely antiviral agent that targets and inhibits the pUL97 protein kinase and its pure substrates.1
In November 2021, maribavir obtained U.S. Food and Drug Administration (FDA) approval, below the model title LIVTENCITYTM, for the remedy of adults and pediatric sufferers (12 years of age or older and weighing at the least 35 kg) with post-transplant cytomegalovirus (CMV) an infection/illness that’s refractory to remedy (with or with out genotypic resistance) with ganciclovir, valganciclovir, cidofovir, or foscarnet. In addition to awaiting a last European Commission choice, regulatory filings are underway with different well being authorities worldwide.
About Takeda’s SOLSTICE Trial
The TAK-620-303 (SOLSTICE) trial (NCT02931539, EudraCT 2015-004725-13) was a world, multicenter, randomized, open-label, active-controlled superiority trial to assess the efficacy and security of remedy with both maribavir or standard antiviral remedy in 352 hematopoietic stem cell transplant and stable organ transplant recipients with CMV an infection refractory, with or with out resistance, to one or a mixture of the standard antiviral therapies: ganciclovir, valganciclovir, foscarnet or cidofovir. Adult sufferers underwent a 2-week screening interval, adopted by randomization 2:1 to maribavir (n=235) (400 mg, twice each day) or standard antiviral therapies (n=117) (as dosed by the investigator) for up to 8-weeks. After completion of the remedy interval, topics entered a 12-week follow-up part.2
The trial’s major efficacy endpoint was confirmed CMV DNA degree <LLOQ (decrease restrict of quantification, [i.e. <137 IU/mL] in 2 consecutive samples separated by at the least 5 days as assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV take a look at) at the finish of Week 8. The key secondary endpoint was CMV DNA degree <LLOQ and CMV an infection symptom management* at the finish of Study Week 8 with upkeep of this remedy impact via Study Week 16.2
About Takeda
Takeda is a world, values-based, R&D-driven biopharmaceutical chief headquartered in Japan, dedicated to uncover and ship life-transforming therapies, guided by our dedication to sufferers, our individuals and the planet. Takeda focuses its R&D efforts on 4 therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We additionally make focused R&D investments in Plasma-Derived Therapies and Vaccines. We are specializing in growing extremely modern medicines that contribute to making a distinction in individuals’s lives by advancing the frontier of new remedy choices and leveraging our enhanced collaborative R&D engine and capabilities to create a sturdy, modality-diverse pipeline. Our workers are dedicated to bettering high quality of life for sufferers and to working with our companions in well being care in roughly 80 international locations and areas. For extra data, go to https://www.takeda.com.
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Medical data
This press launch incorporates details about merchandise that will not be out there in all international locations, or could also be out there below totally different emblems, for totally different indications, in several dosages, or in several strengths. Nothing contained herein needs to be thought of a solicitation, promotion or commercial for any pharmaceuticals together with the ones below improvement.
*CMV an infection symptom management was outlined as decision or enchancment of tissue-invasive illness or CMV syndrome for symptomatic sufferers at baseline, or no new signs for sufferers who have been asymptomatic at baseline
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3. Ramanan P, Razonable RR. Cytomegalovirus infections in stable organ transplantation: a assessment. Infection & Chemotherapy. 2013;45(3):260.
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7. Vanholder, R, et al. Organ donation and transplantation: a multi-stakeholder name to motion. Nature Reviews Nephrology. 2021;17:554-568.
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9. de la Hoz R. Diagnosis and remedy approaches to CMV infections in grownup sufferers. Journal of Clinical Virology. 2002;25:1-12.
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11. Martín-Gandul C, et al. Clinical affect of neutropenia associated with the preemptive remedy of CMV an infection in stable organ transplant recipients. Journal of Infection. 2014;69(5):500-506.
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