Belimumab
| Belimumab | ||
|---|---|---|
| Identifier | ||
| External IDs |
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| Drug information | ||
| ATC code | L04 AA26 | |
| DrugBank | DB08879 | |
| Drug class | Monoclonal antibody | |
Belimumab is a monoclonal antibody that is used in the treatment of systemic lupus erythematosus (SLE).
Marketing approval
The approval by the American health authority FDA for the treatment of SLE took place in March 2011, shortly afterwards, in July 2011, the approval of Benlysta in the European Union followed . Belimumab is manufactured by GlaxoSmithKline .
Properties and appearance
Belimumab is a recombinantly produced human monoclonal antibody of the IgG1λ type. This antibody consists of 1332 amino acids and is produced in an NS0 cell line .
effect
Systemic lupus erythematosus (SLE) is a rare autoimmune disease in which the immune system turns against healthy cells and tissues of the body. This disease is clinically characterized by arthralgia , arthritis , skin rashes or a disorder of the central nervous system . Belimumab binds to the soluble B-cell activating factor Baff ( B cell activating factor of the TNF family , also known as B-lymphocyte stimulator (BLyS)), a cytokine , and inhibits its biological activity. Produced Baff mainly of monocytes and neutrophils . By inhibiting BLyS, the lifespan of B lymphocytes is reduced and the levels of immunoglobulins and complements normalize .
Clinical information
Belimumab is infused several times , with the first three doses 14 days apart, then every four weeks thereafter. The most common side effects with belimumab are bronchitis , nausea and diarrhea .
Early benefit assessment
In Germany, since 2011, newly approved drugs with new active ingredients must be subjected to an " early benefit assessment " by the Federal Joint Committee (G-BA) in accordance with Section 35a SGB V if the pharmaceutical manufacturer wants to achieve a higher sales price than just the fixed amount . Only if there is an additional benefit can the pharmaceutical manufacturer negotiate a price with the umbrella association of statutory health insurance companies. The dossier evaluations, on the basis of which the G-BA makes its decisions, are created by the Institute for Quality and Efficiency in Health Care (IQWiG) .
In 2012, belimumab was compared with an optimized standard therapy (chloroquine / hydroxychloroquine, non-steroidal anti-inflammatory drugs, glucocorticoids, azathioprine, possibly cyclophosphamide) as an additional therapy for adults with active, autoantibody-positive SLE, who show high disease activity despite standard therapy. According to the G-BA decision, there is an indication of a considerable additional benefit.
Finished medicinal products
Benlysta
See also
- Nomenclature of monoclonal antibodies , convention for naming monoclonal antibodies
Web links
- Public Assessment Report (EPAR) of the European Medicines Agency (EMA) for: Belimumab
- Gesundheitsinformation.de: Belimumab (Benlysta) for systemic lupus erythematosus in children and adolescents
Individual evidence
- ↑ Progression to Phase 3 supported by Phase 2 results demonstrating that LymphoStat-B significantly reduces SLE disease activity. GlaxoSmithKline PLC (GSK), archived from the original on August 8, 2014 ; accessed on August 1, 2014 .
- ↑ Benlysta Authorization Details. EMA, accessed July 31, 2014 .
- ↑ FDA approves Benlysta to treat lupus. FDA, accessed July 31, 2014 .
- ↑ a b c d e Assessment Report Benlysta. (pdf) EMA, accessed on July 31, 2014 (English).
- ↑ Belimumab (BENLYSTA®). MedicoConsult GmbH, accessed on July 31, 2014 .
- ↑ a b c Summary of the EPAR for the public Benlysta. (pdf) EMA, accessed on July 31, 2014 .
- ↑ Belimumab - benefit assessment according to Section 35a Social Code Book V (dossier assessment); Accessed March 24, 2020.
- ↑ Benefit assessment procedure for the active ingredient belimumab (systemic lupus erythematosus); Accessed March 24, 2020.
