The Food and Drug Administration (FDA) announced its approval of the intravenous drug Benlysta, to deal with patients with active auto-antibody-positive lupus, making it the first new drug approved for the debilitating condition since the 1950's.
The drug, Benlysta, was developed by Human Genome Sciences (HGS) and can be marketed by that company and GlaxoSmithKline (GSK).
Approval was expected due to the fact an advisory committee towards the F.D.A. had endorsed the drug in November by a 13-to-2 vote, even with reservations of several on the committee that the drug was only marginally effective. The companies have not yet announced the price of Benlysta, but analysts expect it to be about $35,000 a year. Analysts generally expect worldwide sales to eventually exceed $2 billion a year.
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1 comments:
Lupus is an autoimmune disease where the body's immune system becomes hyperactive and attacks normal, healthy tissue. Drug induced lupus is caused by a reaction with certain prescription drugs and causes symptoms very similar to SLE. Thanks a lot...
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