Roche Holding AG's Genentech unit won U.S. Food and Drug Administration approval to market Rituxan to treat adults with a rare autoimmune disease that causes rashes on the skin.
The regulator cleared Rituxan for moderate to severe pemphigus vulgaris, a potentially fatal condition in which progressive painful blisters form on the skin and mucous membranes.
Rituxan is the first approved treatment option for the disease in more than 60 years, Roche said in a statement. It is also the first biologic therapy, a type of treatment derived from living organisms, to be approved by the FDA for pemphigus vulgaris, the Swiss drugmaker said.
Previously, the FDA gave priority review and breakthrough therapy and orphan drug designations to Rituxan to treat the disease. Such designations are intended to encourage the development of medicines for rare disorders or other diseases where there is a need for more treatment options.
The approval is based on the results of the company-funded Ritux 3 study, which compared a combination of Rituxan plus short-term corticosteroids to corticosteroids alone as an initial treatment for patients with newly diagnosed moderate to severe disease.
The main goal of the study was to see whether the disease went into remission at month 24 after treatment without the use of steroids for two or more months. Of those treated with the Rituxan combination, 90% went into remission, compared with 28% of those who took steroids alone.
