FDA awards new drug Maribavir breakthrough drug for cytomegalovirus infection
January 05, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];British drugmaker Shire recently announced that the US Food and Drug Administration (FDA) has awarded the experimental antiviral drug maribavir (SHP620) a breakthrough drug qualification (BTD) for the treatment of cytomegalovirus (CMV) infection in transplant patients. Maribavir belongs to the class of benzimidazole nucleosides, an oral bioavailable antiviral therapy currently under Phase III clinical development to evaluate CMV treatments with CMV infection and current standards. Therapeutic potential in resistant or refractory hematopoietic stem cell transplants or recipients of solid organ transplants.
Maribavir targets the inhibition of CMV's UL97 protein kinase, potentially affecting several key processes of CMV replication, including viral DNA replication, viral gene expression, encapsidation, and escape of mature capsids from the nucleus of infected cells. Previously, in the United States and the European Union, maribavir has been granted a high-risk patient population for the treatment of clinically severe CMV viremia and orphan drug status for immunocompromised patients in the treatment of CMV disease.
Andreas Busch, global head of research and development at Shire, said that maribavir is expected to address the critical medical needs of a population of transplant patients who are resistant or refractory to currently available antiviral therapies. The FDA's grant of maribavir BTD marks an important milestone in the clinical development of the drug.
BTD is a new drug review channel created by the FDA in 2012 to accelerate the development and review of treatments for severe or life-threatening diseases and has preliminary clinical evidence that the drug can substantially improve the condition compared to existing treatments. New drug. Obtaining BTD's drugs will provide closer guidance, including senior FDA officials, during research and development to ensure that patients are offered new treatment options in the shortest possible time.
CMV is a DNA virus of the subfamily of the herpes simplex virus, which is highly species-specific and human being the sole host of human cytomegalovirus (HCMV). CMV is a common virus that infects people of all ages. In the United States, by the age of 40, more than half of adults have been infected with CMV, and most have no associated symptoms and signs. However, in people with low immunity (including organ or stem cell transplant recipients), CMV infection is a serious clinical complication that can lead to tissue invasive disease and ultimately fatal. Its infection is characterized by fever, leukopenia, and thrombocytopenia with or without organ dysfunction. Among the high-risk transplant recipients, two major strategies are currently being used to prevent cytomegalovirus infection: (1) prophylactic treatment with anti-CMV drugs, and (2) monitoring and pre-treatment, also known as preemptive treatment. Existing antiviral therapies are available for the treatment of CMV, but these therapies may be limited due to side effects and/or resistance.
The BTD is based on data from two Phase II clinical studies. One of the studies was conducted in 120 transplant recipients aged 12 years and older who received hematopoietic stem cell transplantation or solid organ transplantation. These patients had CMV infection (viral DNA ≥1000 copies/ml in plasma) and were more responsive to standard treatments. Valganciclovir/ganciclovir or foscarnet is resistant or refractory. In the study, patients were randomized to three doses of maribavir (400 mg, 800 mg, 1200 mg, orally twice daily) for 24 weeks. The primary efficacy endpoint was the proportion of patients who were unable to detect plasma CMV DNA within 6 weeks of treatment, and the primary safety analysis focused on the incidence of treatment-related adverse events.
The study showed that 67% (n = 80/120) of patients achieved the primary efficacy endpoint (95% CI: 57-75). Specifically, the proportion of patients who achieved a primary efficacy endpoint in the maribavir-treated group at 400 mg, 800 mg, and 1200 mg was 70% (95% CI: 53-83), 63 (95% CI: 46-77), and 67% (95%). CI: 51-81). In the study, 30 patients had recurrence of CMV infection, and 7 patients, 11 patients, and 12 patients in the maribavir treatment group at 400 mg, 800 mg, and 1200 mg, respectively.
In terms of safety, the most common adverse event (AE) was dysgeusia (Dysgeusia), which was 64% in all patients, with the incidences of 400 mg, 800 mg, and 1200 mg in the maribavir treatment group being 60% and 63%, respectively. , 73%. In all dose groups, AEs (incidence ≥ 20%) that occurred during other treatments included nausea, vomiting, CMV infection, diarrhea, fatigue, and anemia. An increase in the level of immunosuppressive drugs occurred in 10% of patients. In this study, 27% of patients died of any AE, and one of them (multiple organ failure) was thought to be related to the study drug.
Mervy Prevymis: The first new drug approved for the treatment of CMV infection in the past 15 years
In November 2017, Merck's antiviral drug Prevymis (letermovir) tablets and intravenous preparations were approved by the US FDA for use in CMV serologically positive allogeneic hematopoietic stem cell transplantation (allo-HSCT) adult recipients (R+). To prevent CMV infection. The approval made Prevymis the first new drug approved in the US market for the treatment of CMV infection in the past 15 years.
Unlike maribavir, letermovir belongs to a new class of non-nucleoside CMV inhibitors (3,4-dihydroquinazoline) that inhibit viral replication by targeting the CMV virus terminase complex. In the United States and the European Union, letermovir has previously been granted orphan drug status for high-risk groups to prevent CMV infection. (Sina Pharmaceutical Compilation/newborn)
Article Reference Source: Shire Receives FDA Breakthrough Therapy Designation for Maribavir, an Investigational Treatment for Cytomegalovirus (CMV) Infection in Transplant Patients
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