Roche gets FDA OK for use of Rituxan to treat two rare disorders

The US Food and Drug Administration yesterday approved Swiss drug major Roche (ROG: SIX) subsidiary Genentech’s Rituxan (rituximab), in combination with glucocorticoids (steroids), to treat patients with Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA), two rare disorders that cause blood vessel inflammation (vasculitis).

Rituxan, which has been marketed since 1997, is already indicated for the treatment of patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis. The drug, also marketed as MabThera, posted sales of 6.36 billion Swiss francs ($7.1 billion) last year.

Vasculitis in patients with WG and MPA can lead to tissue damage. WG mostly affects the respiratory tract (sinuses, nose, trachea, and lungs) and kidneys, while MPA commonly affects the kidneys, lungs, nerves, skin, and joints. Both of these diseases affect people of all ages and ethnicities, and both genders. The causes of these disorders are unknown, and both are considered orphan diseases because they each affect less than 200,000 people in the USA.