Human Genome, Glaxo Lupus Drug Needs More Review by U.S. Regulators

Human Genome Sciences Inc. and GlaxoSmithKline Plc’s Benlysta, the first new treatment for lupus in 52 years, needs more review by U.S. regulators before it may be approved for sale.

The Food and Drug Administration extended the deadline for a decision on Benlysta by three months, to March 10, the companies said today in a statement. Human Genome, based in Rockville, Maryland, submitted additional information to the agency after an advisory panel voted 13-2 in support of the drug at a Nov. 16 meeting, according to the statement.

Michael Yee, an analyst at RBC Capital Markets in San Francisco, said Dec. 1 that a delayed decision was likely given the timing of the advisory panel. Benlysta was given a six-month expedited review under an FDA program designed to speed access to novel medicines. If approved, sales of the medicine may exceed $2.1 billion by 2014, according to the average estimate of five analysts surveyed by Bloomberg.

About 5 million people worldwide, including 1.5 million Americans, have lupus. Benlysta prevents the production of antibodies that attack healthy cells, causing swelling, joint and muscle pain, rashes and fever.

Human Genome fell $1, or 3.9 percent, to $24.60 in extended trading on the Nasdaq Stock Market. American depositary receipts of London-based Glaxo, each representing two ordinary shares, dropped 2 cents, to $39.17.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.

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