FDA approves gene Tektrone (Merycin) in combination with glucocorticoids for use in children's GPA and MPA

recently, SwissPharmaceutical(http://giant Roche's GeneTek announced that the U.SFood andDrug(http://Authority (
FDA(http://) has approved Rituxan (Mera, rituximab, ritusxima) in conjunction with the glucocorticoid (GCC) for the treatment of germ polyvarosin (GPA) and microscopic polyvariosis (MPA)About Rituxan
Rituxan is a therapeutic monoclonal antibody that targets CD20 antigens that bind to normal and malignant B cell surfaces and then mobilizes the body's natural defenses to attack and kill labeled B cellsPreviously, Rituxan has been approved to treat four autoimmune diseases in adults, including rheumatoid arthritis (RA), GPA, MPA, and common herpes (PV)this approval, based on data from the PePRS studyThis is the first global study to evaluate Rituxan's treatment of GPA or MPA pediatric patientsThe study, a global, open label, single arm, IIa phase study, enrolled 25 patients with severe, new, or recurrent active GPA or MPA ages ages 6-17, and assessed the safety, efficacy/drug-generation kinetics and exploratory efficacy of the intravenous Rituxan (GCC) dose reduction programIn the study of 25 patients, 19 GPA, 6 cases of MPA, the efficacy of children's vasculitis activity score (PVAS) was assessedThe results showed that 56% of patients reached PVAS remission in the 6th month of treatment, 92% of patients reached PVAS remission in the 12th month of treatment, and 100% reached PVAS remission in the 18th monthsecurity
The safety of Rituxan in children's GPA and MPA patients is consistent with the known Rituxan safety in adult GPA, MPA, rheumatoid arthritis, and normal herpes patients