| Pharmaceutical Information |
| Drug Name |
Daclizumab |
| Drug ID |
BADD_D00570 |
| Description |
Humanized IgG1 Mab that binds to the human interleukin-2 receptor (anti-Tac or anti-CD25). Daclizumab is a composite of human (90%) and murine (10%) antibody sequences. The human sequences were derived from the constant domains of human IgG1 and the variable framework regions of the Eu myeloma antibody. The murine sequences were derived from the complementarity-determining regions of a murine anti-Tac antibody.
On 22 April 2008, Roche Registration Limited chose to voluntarily withdraw the marketing authorization for their product Zenapax (daclizumab), as indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation and used concomitantly with an immunosuppressive regimen like cyclosporine and corticosteroids in patients who are not hight immunized, for commercial reasons and confirmed that this decision was not related to any safety concerns associated with the use of Zenapax (daclizumab) [L1744]. Regardless of the withdrawal of Zenapax, Biogen and Abbvie's Zinbryta (daclizumab), as indicated for the treatment of adult patients with relapsing forms of multiple sclerosis, was approved for use by the FDA in 2016 [L1746].
Despite being approved for use, Zinbryta (daclizumab)'s complex pre-existing safety profile consisting of its restricted availability through a Risk Evaluation and Mitigation Strategy program [L1738] and its black box warning for possible hepatic injury, autoimmune hepatitis, and other immune mediated disorders [L1738] meant its therapeutic usage, adverse effects, and prescribing information was subject to continuous monitoring and updating.
Although Zinbryta (daclizumab) was available for patients as needed until 30 April 2018, Biogen and Abbvie announced a voluntary withdrawal of their product Zinbryta (daclizumab) from the global market on 2 March 2018 [L1738]. This withdrawal was concurrent to the European Medicines Agency announcement of a recall owing to 12 worldwide reports of serious inflammatory brain disorders associated with the use of Zinbryta (daclizumab) [L1738]. |
| Indications and Usage |
Zenapax is a humanized monoclonal antibody used for prevention of renal transplant rejection |
| Marketing Status |
investigational; withdrawn |
| ATC Code |
L04AC01 |
| DrugBank ID |
DB00111
|
| KEGG ID |
D03639
|
| MeSH ID |
D000077561
|
| PubChem ID |
Not Available
|
| TTD Drug ID |
D0P1BZ
|
| NDC Product Code |
Not Available |
| UNII |
CUJ2MVI71Y
|
| Synonyms |
Daclizumab | Dacliximab | Zinbryta | Zenapax | Ro 24-7375 | Ro 24 7375 | Ro 247375 | Ro-24-7375 |
|
| Chemical Information |
| Molecular Formula |
Not Available |
| CAS Registry Number |
152923-56-3 |
| SMILES |
Not Available |
| Chemical Structure |
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| ADRs Induced by Drug |
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