UPDATE 1-Glaxo, Human Genome get fast review for lupus drug

http://www.reuters.com/article/idUSLDE67I13H20100819

UPDATE 1-Glaxo, Human Genome get fast review for lupus drug

Thu Aug 19, 2010 7:57am EDT
* FDA move means Benlysta could be approved by Dec. 9

* First new drug for systemic lupus in more than 50 years

(Adds details on drug, potential approval date)

LONDON, Aug 19 (Reuters) - A keenly awaited new lupus drug from GlaxoSmithKline Plc (GSK.L) and Human Genome Sciences Inc (HGSI.O) will get a priority review from U.S. regulators, potentially clearing the way for its approval by mid-December.

If approved, Benlysta will be the first new drug in more than 50 years for systemic lupus -- a complex disease that causes the immune system to attack the body's own tissue and organs.

The priority review from the Food and Drug Administration means the drug, which is also known as belimumab and was submitted to the agency on June 9, should be reviewed in six months rather than the normal 10.

The two companies said on Thursday the FDA has assigned an action date of Dec. 9 for deciding on the Benlysta application.

The speedy review is good news on two counts. Not only does it mean the drugmakers may be able to book sales earlier than some analysts had expected, but also drugs with priority status are more likely to win a green light from the regulator.

The FDA reserves priority review designation for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. (Reporting by Ben Hirschler; Editing by David Holmes)