The efficacy is re-certified! Roche Melois treatment of normal herpes 2nd Phase III success

On June 13, Roche released positive top-line data for the MabThera/Rituxan (Mertosi, rituxima) treatment of normal-type herpes (PV) PHASE III study of PEMPHIXPEMPHIX is a randomized, double-blind, double-simulated, positive control, parallel arm, multicenter Phase III study conducted in adult patients with moderate to severe active PV who require 60-120 mg/day oral strong pine (or equivalent) and evaluated the efficacy and safety of merofer in relation to standard care therapy (McCophenolic acid (MMF)in thestudy, patients were randomly assigned to two treatment groups: (1) melo-chinese group, 1000 mg intravenous melothea on the first and 15th days, repeat delivery on the 168th and 182nd days, while receiving a placebo matching MMF; (2) MMF group, 1 oral 2g dose of MMF daily, from day 1 to 52 weeks, and a placebo matching melotenThe main endpoint is the proportion of patients who achieve continued complete remission without steroid therapy at week 52 (assessing disease-free activity based on the area index of herpes disease (PDAI) for at least 16 consecutive weeks without steroid therapy)Secondary endpoints include cumulative oral corticosteroid doses, the number of episodes, the time to achieve sustained and complete remission, the time of occurrence of the disease and the health-related quality of liferesults showed that the study reached its main end: a higher percentage of patients in the Merovin group received continued complete remission without steroid therapy than in the MMF groupIn addition, the study reached all secondary endpointsThe adverse events observed in this study are consistent with other autoimmune indications studies in merinasia previouslyThe full data on the study will be released at an upcoming medical conference and will be presented to regulators around the world, including the FDAPV is a rare, serious and potentially life-threatening autoimmune disease characterized by progressive pain blistering in the skin and mucous membranes, accounting for about 80% of herpes casesHerpes is a group of autoimmune diseases caused by autoantibodies produced by B cells in the immune system that attack the proteins that connect between skin epidermal cellsAs these connections divide, the cells separate from each other, causing the skin to separate and form blistersGlobally, it is estimated that about three out of every 100,000 people have been diagnosed with the diseaseMMF is an unapproved PV therapy that has been recognized as a standard care therapyIn June 2018, Mabthera/Rituxan was approved by the United States and the European Union as the first biotherapy for PV, marking the first significant advance in PV clinical treatment in more than 60 yearsThis approval is based on data from Phase III clinical studies on Ritux 3The published PEMPHIX study data will provide additional clinical evidence for the efficacy of Mabthera/Rituxan in the treatment of PVMabthera/Rituxan is a therapeutic monoclonal antibody that targets CD20 antigens that bind to the surface of normal and malignant B cells, and then mobilizes the body's natural defenses to attack and kill labeled B cellsTo date, Rituxan has been approved to treat four autoimmune diseases in adults, including: rheumatoid arthritis, boarly granulator polyvascularitis (GPA) and microscopic polyvascularitis (MPA), and PVjust recently, Mabthera/Rituxan combined glucocorticoids (GCC) supplementary applications for the treatment of GPA and MPA in children 2 years and older were accepted by the FDA and granted priority reviewIf approved, it would be Mabthera/Rituxan's first paediatric indicationGPA and MPA are two rare types of vasculitis, and there is currently no FDA-approved drug for the treatment of childrenRituxan Joint GCC is the only FDA-approved treatment for adult patients with GPA and MPAreference source:1, Phase III PEMPHIX showeded that Roche's Mabthera/Rituxan (rituxi superior) is is to to leave in dedin remission in patients with pemphus perpetuth2, FDA grantsy review to review to's mabthera/ritusan