fda-approval-letter
Specialty Pharmacy

FDA approves expanded Rituxan indication

BY David Salazar

The Food and Drug Administration has approved a new indication for Genentech’s Rituxan. The biologic drug is now indicated to treat adults with moderate-to-severe pemphigus vulgaris, a condition that is characterized by progressive, painful blistering of the skin and mucous membranes.

With this approval — which saw the drug given Priority Review, Breakthrough Therapy Designation and Orphan Drug Designation by the FDA — Rituxan becomes the first biologic therapy for the disease. Genentech said the drug is now indicated to treat four autoimmune diseases.

“Today’s decision by the FDA provides the first approved treatment option in more than 60 years for patients with pemphigus vulgaris, a potentially life-threatening disease,” said Sandra Horning, chief medical officer and head of global product development at Genentech. “We are pleased to offer Rituxan as a new and effective therapy to patients with this serious condition.”

The International Pemphigus and Pemphigoid Foundation estimates that pemphigus vulgaris makes up roughly 80% of the cases of pemphigus, which affects between 30,000 and 40,000 people in the United States.

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