FDA Accept Biologics Application for Subcutaneous Rituximab
Halozyme announced that the Food and Drug Administration (FDA) has accepted Genentech's Biologics License Application for a subcutaneous formulation of rituximab.
This new co-formulation uses Halozyme's proprietary recombinant human hyaluronidase enzyme (‘Enhanze' platform), which may increase the volume of biologics and drugs that can be delivered subcutaneously. “If approved, this formulation has the potential to reduce administration time for patients and health care practitioners,” said Dr. Helen Torley, president and CEO of Halozyme.
Rituximab, CD20-directed cytolytic monoclonal antibody, is indicated for the treatment of moderately-to-severely active rheumatoid arthritis in patients who have had an inadequate response to one or more TNF antagonist therapies, in combination with methotrexate; relapsed or refractory, low-grade or follicular, CD20(+), B-cell non-Hodgkin's lymphoma (NHL); previously untreated follcular, CD20(+), B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as single-agent maintenance therapy; non-progressing (including stable disease), low-grade, CD20(+), B-cell NHL as a single agent after first-line CVP chemotherapy; previously untreated diffuse large B-cell, CD20(+) NHL (DLBCL) in combination with CHOP or other anthracycline-based chemotherapy regimens; CD20(+) chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide; and Wegener's granulomatosis and microscopic polyangiitis, in combination with glucocorticoids.
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