Daclizumab (trade name Zenapax) is a therapeutic humanized monoclonal antibody to the alpha subunit of the IL-2 receptor of T cells. It is used to prevent rejection in organ transplantation, especially in kidney transplants.
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | CD25 |
| Clinical data | |
| Pregnancy category |
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| Routes of administration | intravenous |
| ATC code | |
| Legal status | |
| Legal status |
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| Pharmacokinetic data | |
| Elimination half-life | 20 days |
| Identifiers | |
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| Chemical and physical data | |
| Formula | C6332H9808N1678O1989S42 |
| Molar mass | 142612.1 g/mol g·mol−1 |
Daclizumab is currently in phase II clinical trials in the U.S.
In April 2008, Hoffmann-La Roche, the pharmeceutical company that markets Daclizumab (under the name "Zenapax") in Europe, submitted an application to have its marketing authorisation withdrawn in the EU for commercial reasons. The drug faced diminishing market demand, according to the company. There were no safety concerns with its use. As of January 2009, its marketing authorisation has been withdrawn and the product discontinued completely.[1][2]
It is given in multiple doses, the first 1 hour before the transplant operation and 5 further doses given at two week intervals after the transplant. These saturate the receptors and prevent T cell activation and thus prevent formation of antibodies against the transplant.
Like the similar drug basiliximab, daclizumab reduces the incidence and severity of acute rejection in kidney transplantation without increasing the incidence of opportunistic infections.
Daclizumab usage may also be indicated in place of a calcineurin-inhibitor (ciclosporin or tacrolimus) during the early phase after kidney transplantation, when the kidney is recovering and vulnerable to calcineurin-inhibitor toxicity. This has been shown to be beneficial in non-heart beating donor kidney transplantation.
In the United Kingdom, the National Institute for Health and Clinical Excellence has recommended its use be considered for all kidney transplant recipients.[citation needed]
In 2006 it began a Phase II clinical trial that finished in 2007 as a possible Multiple Sclerosis treatment. Participants were nine patients with multiple sclerosis not controlled with interferon. Daclizumab was effective in reducing lesions and improving clinical scores.[3]
Daclizumab has also been used to slow the progression of autoimmune diseases, particularly that of birdshot chorioretinopathy.[4]
References
- ^ British National Formulary, Edition 57
- ^ EMEA: Withdrawal of the marketing authorisation in the European Union
- ^ Rose JW, Burns JB, Bjorklund J, Klein J, Watt HE, Carlson NG (2007). "Daclizumab phase II trial in relapsing and remitting multiple sclerosis: MRI and clinical results". Neurology. 69 (8): 785–789. doi:10.1212/01.wnl.0000267662.41734.1f. PMID 17709711.
{{cite journal}}: CS1 maint: multiple names: authors list (link) - ^ Sobrin L, Huang JJ, Christen W, Kafkala C, Choopong P, Foster CS (2008). "Daclizumab for treatment of birdshot chorioretinopathy". Arch Ophthalmol. 126 (2): 186–191. doi:10.1001/archophthalmol.2007.49. PMID 18268208.
{{cite journal}}: CS1 maint: multiple names: authors list (link)