New drugs for rare diseases! Novartis anti-inflammatory drug Ilaris approved by FDA: the first drug to treat adult Stila disease (AOSD) !

, June 17, 2020 /PRNewswire
/ -- The U.SFood and Drug Administration (
FDA) recently approvedNovartisanti-inflammatory drug Ilaris (Elili, generic name: canakimumab, kanamono), for the treatment of active syly disease (Still's disease), including adult onset Seiel disease (AOSD)Previously, Ilaris had been granted priority review for the treatment of Steele's disease (Priority Review, PRD)noted that Ilaris was the first drug approved for Steele's diseasePreviously, Ilaris was also approved for the treatment of patients with systemic juvenile isoarthritis (SJIA) age of 2 years"Before today's approval, Steyr patients did not," said DrNikolay Nikolov, Acting Director of Rheumatology and Transplant Medicine,FDA's Center for Drug Evaluation and ResearchFdaapproved treatment for symptoms including painful arthritis, fever and rashToday's approval provides the first treatment option for these patients "
adult Still's Disease (Adult-Onset Still's Disease) is a rare and serious autoimmune disease with an unknown cause autoimmune disease is caused by an abnormality in the immune system that triggers an inflammatory response that damages the body's own tissues AOSD characteristics overlap considerably with systemic juvenile isoarthritis (SJIA), including fever, arthritis, rashes, and elevated inflammatory markers The overlapping characteristics of AOSD and SJIA indicate that this is a disease continuum, not two separate diseases leukocyte interleukin-1 (IL-1) is an important cytokine that regulates the body's immune system and has been demonstrated in AOSD and SJIA Ilaris works by blocking the effects of IL-1 and suppressing inflammation in patients with autoimmune disease The safety and effectiveness of Ilaris's treatment of AOSD is determined by comparable pharmacokinetic exposure, the extrapolation of the established efficacy of Ilaris's treatment of SJIA, and the safety of Ilaris's treatment of AOSD and other diseases Common side effects reported in patients treated with Ilaris included infections (colds and upper respiratory tract infections), abdominal pain, and injection site reactions Ilaris' prescription information includes warnings that IL-1 blocking may increase the risk of serious infection Macrophage activation syndrome (MAS) is a known life-threatening disease that can occur in rheumatic diseases, especially in patients with Steele disease, and should be actively treated Treatment with immunosuppressants may increase the risk of malignant tumor Live vaccination is not recommended during treatment (biovalleybioon.com) original source: FDA
the first treatment for Adult Onset Still's Disease, a Severe and Rare Disease