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Home / MCNTalk / Gene Work Yields New Treatment For Lupus

March 21, 2011

Gene Work Yields New Treatment For Lupus

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.

Read more…

47.608945-122.332015

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