The first new drug to treat lupus in a half century - and the first ever specifically developed to treat the autoimmune disorder - is heading to market in the United States. Under the trade name Benlysta, it is the first federally-approved drug to be derived from genomics, the study of genes and their functions.
Eva Gaskin has been married for 17 years. But one day four years ago, she suddenly was unable to recognize her husband, and became convinced that he had killed her family. Doctors said these strange mental episodes were symptoms of lupus cerebritis, which caused inflammation in her brain tissues.
"I had anxiety. I had insomnia," says Gaskin. "I had lots of things going on that we really did not understand and that was very frightening for my family until I got on the proper treatment, and those kinds of issues started to subside. But at first it was very scary.”
The brain inflammation that made Eva see her husband as a stranger and a killer soon moved to her lungs, and her breathing became painful. Lupus is a potentially fatal disease. It develops when the body's protector cells stop differentiating between healthy cells and bacteria. As a result, the immune system starts attacking its own body instead of protecting it from bacteria, viruses and parasites.
Until now, lupus sufferers have treated their varied symptoms - from mental disorders to skin rashes and painful joints - with a combination of drugs, including painkillers, steroids and anti-malarial medicines. Aside from being insufficient, these treatments have also carried the risk of toxicity.
But now, for the first time in 50 years, the U.S. Food and Drug Adminsitration has approved a new drug specifically to treat lupus.
“It’s so exciting to see that a drug is coming out that targeted specifically for lupus patients because in the past we have been taking drugs that have been found helpful but not specifically for us,” says Gaskin.
Benlysta also represents a medical milestone. Its American developer, Human Genome Sciences, calls it the first drug derived from the genetic mapping of human proteins.
Company vice-president Barry Labinger says the firm is proud of the fact that after so many years of research, development, and clinical trials, they finally have an anti-lupus drug that directly targets the autoimmune disorder.
“Benlysta works on the immune system by blocking a part of the immune system that becomes over-active in the presence of autoimmune disease," says Labinger. "Autoimmnue disease in particular tends to happen far more frequently in women and people of color and so Benlysta turns out to be an important drug for those patients, as well as a broader population for anybody who has lupus.”
Lupus affects women nine times more than it does men. And it occurs disproportionately in African-American, Hispanic and Asian populations.
Labinger says Benlysta is not a miracle drug, and it's not for everyone. “It is a very important step forward. There is room for more than one treatment for lupus patients over time and we hope that this is a first step towards a number of advances for patients with lupus.”
Human Genome Sciences will soon begin a large study of African-American lupus patients.
In the meantime, lupus sufferer Eva Gaskin says her condition is stable for now, but she's relieved she has Benlysta to fall back on if her lupus should flare up again.