Posted from: Friday, July 06, 2018 - 04:25 PM - Present

New Indication Approved for Rituxan

June 7, 2018 – The U.S. FDA has approved a new indication for Rituxan® (rituximab), manufactured by Genentech. It is now approved to treat moderate-to-severe pemphigus vulgaris (PV) in adult patients. Rituxan is the first biologic approved for PV.

Approval for the new indication was based on clinical studies in which 90% of patients who received Rituxan achieved complete remission after 24 months of treatment, versus 28% of patients who were treated only with a corticosteroid. Recommended initial dosing under the new indication is two 1000mg intravenous (IV) infusions given two weeks apart. Patients should also receive a tapering course of glucocorticoids. Twelve months after beginning treatment, patients should be administered a 500mg IV infusion of Rituxan. This dose should be repeated every six months, based on clinical evaluation.

A rare autoimmune disorder, PV leads to painful blistering of the skin and mucous membranes. Mortality rates were high prior to the use of modern treatments, which include corticosteroids. With treatment, PV is fatal in approximately 5% of cases, often due to complications such as systemic infection.

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Last Updated Sunday, September 23, 2018 - 09:34 AM.