As noted in the Wall Street Journal, the Food and Drug Administration approved the first new drug for lupus in more than 50 years, a milestone in the effort to mine data from the human genome to discover and develop new medicines. This development is important for a variety of reasons which highlight various situations within the world of how illnesses are defined and treated. Specifically the article notes that:
- There’s a huge range in the number of people suffering from Lupus, depending upon how the disease is defined: Estimates of how many Americans are affected range from 161,000 to 1.5 million.
- One version of the drug entered clinical trials in 2000. So little was known about how to evaluate a new lupus drug, however, that it took the company, outside experts and the FDA took a year to design clinical trials that would determine whether Benlysta helped patients or not.
- Benlysta, the drug in question, is one of the first drugs discovered based on mapping of genomic data to make it through to FDA approval.
- The price of the drug will be about $35,000 a year per patient, which the company said was in the range of other biologic therapies used to treat similar diseases.
- Clinical studies also showed those receiving Benlysta suffered more deaths and serious infections compared with patients not on the drug. (Patients using Benlysta will receive a medication guide that will outline the risks associated with the product.)
- Before Benlysta, the FDA last approved drugs to treat lupus in 1955.
- Nine out of ten people with Lupus are women.