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

* 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 (BestGrowthStock) – 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)

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