In early November 2009, Human Genome Sciences, Inc. (HGS) and GlaxoSmithKline PLC announced that BENLYSTA™ (belimumab), an experimental lupus drug, has completed testing and is headed to the Food and Drug Administration (FDA) for approval. H. Thomas Watkins, President and Chief Executive Officer of HGS, said that the drug trails “confirm our view that BENLYSTA has the potential to become the first new approved drug in decades for people living with systemic lupus.” Marketing applications will be submitted in the first half of 2010. Human Genome Sciences will work with GlaxoSmithKline to place the drug on the market.
Human Monoclonal Antibody Drug
Belimumab is a human monoclonal antibody drug that recognizes and inhibits the biological activity of B-lymphocyte stimulator, a naturally occurring protein discovered by HGS. The protein stimulates the development of cells which, when mature, produce antibodies, the body’s first line of defense against foreign bodies and infection. In lupus and certain other autoimmune diseases, too many cells are created and set up a situation where autoantibodies attack and destroy healthy tissue. Belimumab can reduce autoantibody levels in patients with systemic lupus erythmatosus.
- Antibodies, or any of a large number of proteins of high molecular weight that are produced normally by specialized B cells, are produced when stimulated as an immune response against substances foreign to the body.
- Monoclonal antibodies are produced when many cells of the same type are created from a single antibody cell in a laboratory culture.
- Human monoclonal antibodies are large quantities of identical antibody molecules produced from a single human cell. The population of cells produces identical antibody molecules. These antibodies are called monoclonal antibodies because they are produced by the identical offspring of a single, cloned antibody producing cell. Once a monoclonal antibody like belimumab is made, it can be used to track down the specific protein that induced its formation.
Systemic Lupus Erythematosus (SLE)
SLE is a chronic, life-threatening autoimmune disease, or a disease caused by autoantibodies (antibodies that attack molecules, cells, or tissues of the organism producing them).
According to the Lupus Foundation of America, approximately five million people worldwide, including approximately 1.5 million in the United States, suffer from various forms of lupus, including SLE. Lupus can occur at any age, but appears mostly in young people ages 15 to 45. About 90 percent of those diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash, and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders.
Genetic Studies Reveal How Lupus Works
In January 2008, studies were released that discussed the steps forward that had been made in understanding how the disease works. The studies looked at genetics and variations in a single DNA base pair, called single nucleotide polymorphisms (SNP). A pattern of genetic variation occurs in a SNP among individuals diagnosed with lupus.
In lupus patients, this variation of the SNP pattern, when compared to individuals without lupus, changes the DNA protein product so that it functions differently. This small variation may alter the expression or function of the protein encoded by that gene in a way that contributes to the disease.
Field of Biotechnology
The field of biotechnology blossomed following the early 1980s discovery of how to make a polymerase chain reaction happen in the laboratory. This breakthrough made possible the sequencing of the human genome and the many related breakthroughs -- in areas from pharmaceuticals to genealogy studies -- that have followed.
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