Roche Holding AG said the U.S. Food and Drug Administration expanded the marketing approval for Rituxan to treat children affected by two rare kinds of blood vessel disorders.
The approval was given to Genentech Inc., a unit of the Swiss drugmaker. Rituxan, in combination with glucocorticoids, is now approved to treat granulomatosis with polyangiitis and microscopic polyangiitis in children ages two years or older. Both GPA and MPA are rare, potentially life-threatening diseases that cause inflammation primarily affecting the small and medium blood vessels.
The U.S. regulator initially approved the combination of Rituxan and glucocorticoids, a class of steroid, to treat these two diseases in adults in 2011.
Rituxan, or rituximab, was granted a priority review for this indication by the FDA in June. The designation is assigned to drugs that can treat serious conditions and may provide a significant improvement in safety or efficacy. The combination is the only approved treatment for children with GPA or MPA.
The drug is also approved by the FDA to treat adults with two other autoimmune diseases: rheumatoid arthritis and pemphigus vulgaris.
Roche generated CHF 3.34 billion from global sales of Rituxan during the first half of 2019.
