Anifrolumab, sold under the brand name Saphnelo, 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
systemic lupus erythematosus (SLE).
It binds to the
type I interferon receptor, blocking the activity of
type I interferons such as interferon-α and interferon-β.
Anifrolumab was approved for medical use in the United States in July 2021,
and in the European Union in February 2022.
The U.S.
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
considers it to be a first-in-class medication.
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Mechanism of Action
In systemic lupus erythematosus, the body can produce a great amount of type 1 interferon, which activates the immune system excessively and creates problems for lupus patients. Anifrolumab acts to block INF-1 from sending signals to other immune cells, which prevents the body from being attacked by itself.
Adverse effects
The most common adverse effect was
shingles, which occurred in 5% of patients in the low-dose group, to 10% in the high-dose group, and to 2% in the
placebo
A placebo ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like saline), sham surgery, and other procedures.
In general, placebos can af ...
group. Overall adverse effect rates were comparable in all groups.
History
The drug was developed by
MedImmune
MedImmune, LLC was a wholly owned subsidiary of AstraZeneca before February 14, 2019, when it was announced that the MedImmune name and branding would be discontinued in favor of AstraZeneca.
MedImmune was founded in 1988 as Molecular Vaccines, ...
, a unit of
AstraZeneca
AstraZeneca plc () is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas includi ...
, which chose to move anifrolumab instead of
sifalimumab into phase III trials for lupus in 2015.
Society and culture
Legal status
On 16 December 2021, 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 responsible for elaborating the agency's opinions on all issues regardin ...
(CHMP) of the
European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Saphnelo, intended for the treatment of moderate to severe systemic lupus erythematosus (SLE).
The applicant for this medicinal product is AstraZeneca AB.
Anifrolumab was approved for medical use in the European Union in February 2022.
Names
Anifrolumab is the international nonproprietary name (INN).
References
Further reading
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External links
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Cutaneous lupus erythematosus
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