Rituxan receives breakthrough status from FDA

Genentech's drug Rituxan was recently granted Breakthrough Therapy Designation Status by the U.S. Food and Drug Administration.
Rituxan was created to treat emphigus vulgaris, a rare life-threatening condition that involves progressive skin and mucous membrane blistering. There are limited treatment options for dealing with the condition.
The company noted in its press release that the FDA’s designation exists to help expedite development and review of medicines that show early evidence of possible benefit for fighting life-threatening conditions. The FDA uses this designation to make sure at-risk patients receive access to potential life-saving medicines as quickly as possible. Genentech's Phase 3 study is enrolling patients.
“People with pemphigus vulgaris need more options and we look forward to working with the FDA to make Rituxan available to patients with this potentially deadly disease,” Dr. Sandra Horning, chief medical officer and head of global product development, said. “We are committed to developing therapies that target B cells in areas of unmet need across a range of immune and malignant diseases, including new antibody constructs that enhance efficacy, safety or both.”