Regulators should reach a decision by early December on an experimental lupus drug made by Human Genome Sciences and GlaxoSmithKline, the companies said Thursday.
The Food and Drug Administration is conducting a priority review of Benlysta as a treatment for systemic lupus. If approved, Benlysta would be the first new lupus drug to reach the market in more than 50 years.
The FDA gives priority reviews to products that could significantly improve existing treatments, or that provide hope for an illness for which no treatment has been approved.
The companies filed for FDA approval in June. Human Genome Sciences Inc., of Rockville, Md., and GlaxoSmithKline PLC, of Britain, are also seeking approval to market Benlysta in Europe.
A decision is expected by Dec. 9.