The FDA approves Benlysta for a New Lupus Drug
The Food and Drug Administration (FDA) announced its approval with the intravenous drug Benlysta, to treat patients with energetic auto-antibody-positive lupus, which makes it the primary new drug approved for the debilitating condition since the 1950’s.
Approval was expected since an advisory committee to the F.D.A. had endorsed the drug in November by a 13-to-2 vote, despite reservations of numerous about the committee that the drug was only marginally efficient.
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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