On Wednesday the Food and Drug Administration announced its approval of a drug designed for the treatment of lupus; the first of its kind to hit the market in more than 50 years. The drug, called Benlysta, helps manage the symptoms of lupus, an immune disease that attacks the organs of the body. The drug works by restraining the bodily protein B-lymphocyte stimulator which causes the creating of auto antibodies when it reaches elevated levels. The auto antibodies attack healthy skin, kidney, heart and joint cells. “We expect to have this novel therapy available to physicians and patients within about two weeks, and our entire organization looks forward to the positive impact we hope this new therapy will have for patients with systematic lupus”, said H. Thomas Watkins on Wednesday.
The drug was developed in a partnership between Human Genome Sciences of Rockville and GlaxoSmithKline.
As expected, the approval of the drug led to a spike in stock prices for the developing organizations and Glaxo’s shares were up by close to 4% after hours.
The negative side of the drug is that the price of it is in the neighborhood of $35,000 each year for one patient. This is a huge price tag, equal or greater than the yearly salaries of many individuals. The only way they could even hope to afford this drug is to find a beneficiary with lots of money willing to pay for their treatment, or to gain approval for a claim for the medication by their health insurance company.
In addition, a panel of external medical experts was concerned about the small amount of safety data available on the drug and questioned its safety for use by African-American patients. The FDA itself admitted to the fact that African Americans didn’t respond very well to the treatments and that additional research would be needed to conclude how the use of the drug could affect the people of this heritage.
It’s obvious that the discovery and acceptance of this drug is great news for lots of people, but I would have thought responsible researchers would explore the impact of such an expensive drug on people of all races before it was approved for mass usage. However, a treatment is better than no treatment at all.