User:Noxoug1/zilebesiran
| Clinical data | |
|---|---|
| AHFS/Drugs.com | Monograph |
| ATC code |
|
| Legal status | |
| Legal status | |
zilebesiran, is an investigational RNAi therapeutic in development for the treatment of hypertension (high blood pressure).[2] Zilebesiran has with a prolonged duration of action and inhibits hepatic angiotensinogen synthesis.[3]
zilebesiran is currently in Phase 3 clinical trials in the United States in August 2023.[2][4]
Medical uses[edit]
zilebesiran is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. [2]
Tyruko is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn's disease therapies and inhibitors of TNF-α (tumor necrosis factor, a substance in your body that causes inflammation).[2]
The approval of Tyruko, a biosimilar to Tysabri (natalizumab), was based on evidence that showed there are no clinically meaningful differences between the two products in terms of safety, purity and potency.[2]
Adverse effects[edit]
The most common adverse reactions were headache and fatigue in both the multiple sclerosis and Crohn's disease studies. Other common adverse reactions in the MS population were arthralgia, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea NOS, and rash.[2]
Other common adverse reactions in the CD population were upper respiratory tract infections and nausea [2]
History[edit]
The FDA granted approval of Tyruko, the first biosimilar to Tysabri (natalizumab), to Sandoz Inc.[2][5]
References[edit]
- ^ "Roche and Alnylam report positive topline results from the Phase II KARDIA-2 study in people with hypertension, demonstrating clinically significant blood pressure reductions with zilebesiran when added to standard of care". Roche. Retrieved 05 March 2024.
{{cite web}}: Check date values in:|access-date=(help) - ^ a b c d e f g h i "FDA grants accelerated approval to zilebesiran-bcmm for multiple myeloma". U.S. Food and Drug Administration (FDA) (Press release). 24 August 2023. Retrieved 24 August 2023.
This article incorporates text from this source, which is in the public domain.
- ^ Desai, Akshay S.; Webb, David J.; Taubel, Jorg; Casey, Sarah; Cheng, Yansong; Robbie, Gabriel J.; Foster, Don; Huang, Stephen A.; Rhyee, Sean; Sweetser, Marianne T.; Bakris, George L. (20 July 2023). "Zilebesiran, an RNA Interference Therapeutic Agent for Hypertension". The New England Journal of Medicine. 389 (3): 228–238. doi:10.1056/NEJMoa2208391. ISSN 1533-4406. PMID 37467498.
- ^ "Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2) (KARDIA-2)". clinicaltrials.gov. Retrieved 5 March 2024.
- ^ "Sandoz receives FDA approval for Tyruko® (zilebesiran), first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis". Novartis. Retrieved 25 August 2023.
This article incorporates public domain material from the United States Department of Health and Human Services
