Rozrolimupab

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Rozrolimupab
Clinical data
ATC code
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Identifiers
CAS Number
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Chemical and physical data
Molar massAntibodies 144.8–148.8 kg/mol
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Rozrolimupab is a recombinant antibody mixture, specifically containing 25 Rhesus D, or RhD, human antibodies, and is currently under development by Symphogen for the treatment of immune thrombocytopenic purpura (ITP) and for the prevention of hemolytic disease of the newborn (HDN).[1][2]

Clinical trials

Phase two trials have proved to be promising. Utilizing a single intravenous infusion dosing, this phase was held in 41 centers across the United States, Europe, and Asia in order to evaluate an effective dose.[1] The 61 patient study was assessing rozrolimupab's ability to effectively treat ITP and HDN as well as how safe and tolerable the drug is. Common adverse effects included mild to moderate headache, pyrexia, chills, and fatique. The study showed that administration of the drug did effect platelet responses in the blood, with a median time of response of roughly two and a half days, and on average lasting a total of 14 days.[3]

Current ITP and HDN treatment

While the current blood-derived treatment has proved successful, its dependence on a donor population proves problematic. Rozrolimupab's manufactured antibody mixture may be an alternative.[1]

References

  1. ^ a b c "Symphogen Rozrolimupab". Archived from the original on 2013-05-13. Retrieved 2013-12-11.
  2. ^ Easdale S, Stasi R (July 2013). "Rozrolimupab, a first-in-class recombinant monoclonal antibody product for primary immune thrombocytopaenia". Expert Opinion on Biological Therapy. 13 (7): 1085–92. doi:10.1517/14712598.2013.800856. PMID 23688321. S2CID 27029201.
  3. ^ "Symphogen Pressroom". Archived from the original on 2013-12-11. Retrieved 2013-12-11.