The US Food and Drug Administration have given its stamp of approval on Benlysta, a medication designed for treating lupus erythematosus, considered as a breakthough in health care. According to a report by The Wall Street Journal, the drug is not only the first medication approved for lupus but also the first to be derived from the study of genes.

It took several years to develop Benlysta and is a collaboration of Human Genome Sciences, Inc. and GlaxoSmithKline. It has undergone through 20 years of development in the former’s laboratory. Lupus affects 1.5 million Americans, with women nine times more prone to the disease than men.

The FDA approved its use for treating active systemic lupus erythematosus after seeing proof from two clinical studies that it is safe and efficient. Involving over 1,500 participants, the two studies demonstrated favorable results in reducing flare-ups while allowing patients to minimize their steroid medications, although these were not clearly established.

However, a report by the Associated Press revealed that study results also showed that Benlysta is not effective for the most severe form of lupus and worked in only 35 percent of the North American participants. One problem about the drug is that it did not show any favorable results for the African American participants. Upon request from the FDA, Human Genome Sciences acceded to conduct a new study to determine whether using Benlysta is safe among African Americans and those with African origin.

Benlysta is administered intravenously. As many of the participants had reactions from their IV infusions, the FDA recommends using antihistamines prior to treatment. Among the usual side effects of Benlysta include nausea, fever, and diarrhea, but there were also incidence of deaths and serious infections among the participants who administered Benlysta against the placebo drug.

When administering Benlysta, the patient should not take any vaccines. Along with the drug, a medication guide should be provided to patients so they will understand the potential risks involved.

Benlysta is expected to give hope to around 200,000 current lupus patients and may also pave the way for developing new trends in the treatment of lupus.

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