The US Food and Drug Administration (FDA) has approved the first drug in 56 years for the treatment of lupus erythematosus, the most common form of the disease, the agency’s press office said. Registration of the preparation in Europe is expected in the second half of 2011.
A drug called Benlysta (belimumab) has been developed by the innovative company Human Genome Science together with the pharmaceutical company GlaxoSmithKline. It is administered as injections every 28 days, and the cost of treating one patient is PLN 35. dollars a year.
It is expected to be one of the most profitable drugs. In 2015, the value of its sales is expected to amount to at least USD 2-3 billion annually, and in the following years it may increase to as much as USD 5 billion.
The FDA has approved the drug, although its effectiveness is not very high. Pre-registration clinical trials showed that the drug improved in 43,2 percent. patients compared to 33,8 percent. patients who were only receiving placebo at the same time.
In eleven treated patients, only one will improve symptoms, the FDA admits.
Benlysta gives better results in white people. It is not known why African Americans respond less to it because they have a more aggressive form of lupus. The FDA has so far approved studies to clarify this.
The drug cannot be used in patients with severe damage to the kidneys and the central nervous system, because it has not been tested in them. It also mentioned that people who received it had more deaths than those who received a placebo.
Despite the reservations, it was decided to approve the drug for use, and it was decided by a vast majority of the votes of the opinion committee members (13 to 2), due to the limited therapeutic potential of lupus.
Dr. Lenore M. Buckley of Virginia Commonwealth University said that there is a huge demand for even a low-efficacy formulation. The FDA also hopes that this will encourage other pharmaceutical companies to develop more drugs for the disease.
Patients only have a handful of older-generation drugs, such as Roche’s CellCept, and steroids, which also cause numerous side effects. Prednisone, one of the frequently used steroids, lowers immunity, causes obesity and osteoporosis, promotes high blood pressure, diabetes and gastric ulcer disease, as well as insomnia and depression.
Benlysta is a monoclonal antibody that blocks the action of B-type lymphocytes, immune cells that produce antibodies that destroy the so-called antigens. In people with lupus, they can therefore inhibit these lymphocytes, which, due to disorders of the immune system, enter the bloodstream and attack their own tissues.
The first symptom of the disease is a characteristic butterfly-shaped erythema appearing on the skin of the face, giving the patient the appearance of a wolf (hence its name – lapus, which means wolf in Latin). Later, almost all joints, tissues and organs of the patient may be affected. At first, however, only one organ is attacked, and the disease often goes back and forth.
In people with severe disease, when all organs are attacked, lesions in the heart and kidneys appear similar to those in people who are advanced in age. In thirty-year-olds with lupus, the coronary vessels may be in the same condition as in a person aged 65. Over 80 percent survives no more than 10 years from the diagnosis of the disease.
Lupus is the most common autoimmune disease. Worldwide, 5 million people suffer from it. In the USA, the number of patients is estimated at 1,5 million Americans, and in Poland – from 40 to 80 thousand. patients. Women suffer most often, with as much as 80 percent. illnesses.
Zbigniew Wojtasiński (PAP)