Rituximab is under clinical development by Biogen and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.
According to GlobalData, the latest event to affect Rituximab’s likelihood of approval (LoA) and phase transition for Neuromyelitis Optica (Devic’s Syndrome) took place on 21 Jun 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.
GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Rituximab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.
Rituximab (MabThera, Rituxan, Ristova) is an anti-neoplastic agent. It is formulated as an injectable concentrate for solution for intravenous route and solution for subcutaneous route of administration. Rituximab intravenous formulation is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy; as maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy; as monotherapy indicated for treatment of adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy; for the treatment of adult patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy; in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL) and for the treatment of patients with previously untreated and relapsed/refractory CLL. Rituximab in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies; in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA); in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active GPA (Wegener’s) and MPA and for the treatment of patients with moderate to severe pemphigus vulgaris (PV). Rituximab subcutaneous formulation is indicated in adults for Non-Hodgkin’s lymphoma (NHL): for previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy; as maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy and for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Rituxan is indicated for the prevention of recurrence of neuromyelitis optica spectrum disorder (including neuromyelitis optica).
It is under development for neuromyelitis optica (Devic’s syndrome), post-transplant lymphoproliferative disorder, refractory chronic inflammatory demyelinating polyneuropathy (CIDP), fibrillary glomerulonephritis, systemic sclerosis, melanoma, mucosa-associated lymphoid tissue lymphoma, schizophrenia spectrum disorder and obsessive-compulsive disorder and for paediatric patients with severe, active GPA (Wegener’s), marginal zone B-cell lymphoma, nodal marginal zone B-cell lymphoma, extranodal marginal zone B-cell lymphoma (mucosa-associated lymphoid tissue or MALT-lymphoma), splenic marginal zone B-cell lymphoma, microscopic polyangiitis (MPA), previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL) and Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL). It was under development for lupus nephritis, membranous nephropathy, refractory myasthenia gravis, Sjogren's syndrome, anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA vasculitis), systemic lupus erythematosus, hemophilia A, idiopathic thrombocytopenic purpura (immune thrombocytopenic purpura), granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) in the US, primary progressive multiple sclerosis (PPMS) and relapsing-remitting multiple sclerosis.
Biogen is a biopharmaceutical company that discovers, develops, and delivers drugs and biosimilars for the treatment of various neurological and neurodegenerative diseases. The company’s marketed products include Avonex (interferon beta-1a), Tysabri (natalizumab), Tecfidera (dimethyl fumarate), Fampyra (prolonged-release fampridine tablets), and Plegridy (peginterferon beta-1a) for the treatment of multiple sclerosis (MS); Spinraza (nusinersen) for spinal muscular atrophy (SMA); and Fumaderm (fumaric acid esters) for severe plaque psoriasis. It has several product candidates targeting various indications such as MS, Parkinson’s disease, CNS and neuromuscular disorders, Alzheimer’s disease, and idiopathic pulmonary fibrosis and stroke. The company sells its products through direct sales force, marketing groups, and distributors in the Americas, Europe, Asia, and other territories. Biogen is headquartered in Cambridge, Massachusetts, the US.
Quick View Rituximab LOA Data
|Highest Development Stage|