Biogen Idec, Genentech receive FDA priority review for Rituxan treatment of rheumatoid arthritis

New York, Oct. 31 - Biogen Idec, Inc. and Genentech, Inc. said the Food and Drug Administration has granted their request for priority review of the use of Rituxan (Rituximab) for patients with rheumatoid arthritis who respond inadequately to anti-TNF therapy.

The priority designation gives the FDA up to six months to take action on the supplemental Biologics License Application.

The companies said the submission was based primarily on 24-week results of a multi-center, randomized, double-blind, placebo-controlled phase III study known as Reflex.

In the trial, patients who received a single course of two infusions of Rituxan with a stable dose of methotrexate displayed a statistically significant improvement in symptoms, as measured by American College of Rheumatology 20 response, compared to those who received a placebo and methotrexate, Biogen Idec and Genentech said. The results of the Reflex trial will be presented at the American College of Rheumatology annual meeting in San Diego in November.

The most common side effects included headaches, upper respiratory tract infection and nasopharyngitis. Analysis of the Reflex 24-week data did not reveal any unexpected safety signals, and the companies continue to monitor the long-term safety of Rituxan in all clinical trials.

Rituxan is a therapeutic antibody that targets and selectively depletes CD20-positive B-cells without targeting stem cells or existing plasma cells.

Rituxan is also being studied in other autoimmune diseases, including lupus, multiple sclerosis and ANCA-associated vasculitis.

Rituxan received FDA approval in November 1997 for the treatment of relapsed or refractory low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma.

Biogen Idec is a Cambridge, Mass., company focusing on oncology, neurology and immunology. Genentech is a South San Francisco, Calif., biotechnology company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.