New Indication for Rituxan

NOVEMBER 01, 2005
Susan Farley

Biogen Idec Inc and Genentech Inc, makers of the therapeutic antibody Rituxan, submitted a supplemental biologics license application with the FDA acknowledging a new indication for Rituxan—as a treatment for rheumatoid arthritis (RA) in patients who do not respond properly to anti-tumor necrosis factor (anti-TNF) therapy. The manufacturers based their claims on results of a 24-week, multicenter, randomized, double-blind, placebo-controlled phase 3 study known as REFLEX. The study measured patient response to a single course of 2 infusions of Rituxan plus a dose of methotrexate and found a statistical improvement of symptoms in 24 weeks, compared with a combination of placebo plus methotrexate. According to Genentech's Senior Vice President and Chief Medical Officer Hal Barron, MD, "Rituxan may provide a potential new treatment approach for the RA patient population with the greatest unmet medical need."

Ms. Farley is a freelance medical writer based in Wakefield, RI.




SHARE THIS SHARE THIS
0
 

The Oncology Care Pharmacist in Health-System Pharmacy 
According to the National Cancer Institute, almost 40% of men and women will be given a diagnosis of some form of cancer in their lifetime.


 

Pharmacy Times Strategic Alliance
 

Conference Coverage
News from the year's biggest meetings


Pharmacist Education
Clinical features with downloadable PDFs


 

SIGN UP FOR THE PHARMACY TIMES NEWSLETTER
Personalize the information you receive by selecting targeted content and special offers.