Rozanolixizumab, sold under the brand name Rystiggo, is a
monoclonal antibody
A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell.
Monoclonal antibodies ...
used for the treatment of
myasthenia gravis
Myasthenia gravis (MG) is a long-term neuromuscular junction disease that leads to varying degrees of skeletal muscle weakness. The most commonly affected muscles are those of the eyes, face, and swallowing. It can result in double vision, ...
.
Rozanolixizumab is a humanized and chimeric monoclonal antibody;
and is a neonatal Fc receptor blocker.
The most common adverse reactions include headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.
[ ]
Rozanolixizumab was approved for medical use in the United States in June 2023,
and in the European Union in January 2024.
Medical uses
Rozanolixizumab is
indicated
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...
for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive.
Society and culture
Names
Rozanolixizumab is the
international nonproprietary name.
Legal status
In November 2023, the
Committee for Medicinal Products for Human Use
The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee
A committee or commission is a body of one or more persons subordin ...
(CHMP) of the
European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Rystiggo, intended for the treatment of myasthenia gravis.
The applicant for this medicinal product is UCB Pharma.
[ Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.] Rozanolixizumab was approved for medical use in the European Union in January 2024.
References
External links
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{{Authority control
Immunosuppressants
Monoclonal antibodies
Orphan drugs