Itolizumab
- none
- Approved in India
- 1116433-11-4 N
- none
- XQQ2RHV14N
- D12426
Itolizumab (INN, trade name Alzumab) is a 'first in class' humanized IgG1 monoclonal antibody developed by Biocon[1] and the Center of Molecular Immunology (CIM), Havana.[2]
Mechanism of action
It selectively targets CD6, a pan T cell marker involved in co-stimulation, adhesion and maturation of T cells. Itolizumab, by binding to CD6, down regulates T cell activation, causes reduction in synthesis of pro-inflammatory cytokines and possibly plays an important role by reducing T cell infiltration at sites of inflammation.[3]
Clinical trials
A double blind, placebo controlled, phase III treat –Plaq study of itolizumab successfully met the pre-specified primary end-point of significant improvement in PASI-75 (Psoriasis Area and Severity Index) score after 12 weeks of treatment in patients with moderate to severe psoriasis compared to placebo.[4]
Applications
Biocon received marketing authorization for the drug from the Drugs Controller General of India (DCGI) in January 2013 and marketing within India commenced in August 2013.[1][5]
In July 2020, Biocon received authorization in India for its use in the treatment of COVID-19.[6]
References
- ^ a b Jayaramun K (December 2013). "Biocon's first-in-class anti-CD6 mAb reaches the market". Nat. Biotechnol. Vol. 31, no. 12. United Kingdom. pp. 1062–3.
- ^ "India prepares to test Itolizumab, the drug credited for lowering Covid mortality in Cuba". May 30, 2020.
- ^ "Biocon Receives Marketing Authorization for its Novel Biologic Itolizumab for Psoriasis" (PDF). Biocon Limited. 8 January 2013.
- ^ Urs A (10 January 2012). "Biocon's test shows positive results for Itolizumab". @businessline.
- ^ "Biocon's psoriasis drug, Itolizumab receives DCGI marketing authorization". Pharmabiz.com. India: Saffron Media. January 8, 2013.
- ^ "Biocon's Itolizumab approved for COVID-19 treatment: All you need to know". The Economic Times. Retrieved 2020-07-14.
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- #WHO-EM
- ‡Withdrawn from market
- Clinical trials:
- †Phase III
- §Never to phase III
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