The FDA approves Benlysta for a New Lupus Drug
The Food and Drug Administration (FDA) announced its approval with the intravenous drug Benlysta, to deal with patients with active auto-antibody-positive lupus, making it the primary new drug accepted for that debilitating issue 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 anticipated because an advisory committee towards the F.D.A. had endorsed the drug in November by a 13-to-2 vote, regardless of reservations of numerous about 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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