UPDATE 2-FDA delays decision on Human Genome lupus drug

* New approval decision date March 10

* Could be first new lupus treatment in half century

* Human Genome shares fall 4 percent
(Adds original action date, requested data submitted, updates
share price)

NEW YORK, Dec 3 (BestGrowthStock) – U.S. health regulators delayed
a decision on whether to approve the experimental lupus
treatment Benlysta being developed by Human Genome Sciences Inc
(HGSI.O: ), sending the company’s shares down 4 percent.

The new Food and Drug Administration action date for the
medicine is March 10, Human Genome and its Benlysta development
and marketing partner GlaxoSmithKline (GSK.L: ) said on Friday. A
decision had been expected by Dec. 9.

Such delays are not uncommon and do not necessarily mean
there is a problem with the drug, but they are typically
frowned upon by the investment community.

This case has likely been delayed to give the FDA more time
to review additional data for which it asked Human Genome in
mid-November.

The company said on Friday that it had submitted the data.

If approved, Benlysta, known chemically as belimumab, would
become the first new lupus treatment to hit the U.S. market in
half a century.

An FDA expert advisory panel recommended the drug’s
approval by a vote of 13-2 in November. Analysts expect it to
become a multibillion-dollar blockbuster.

Lupus, a debilitating and sometimes fatal disease, causes
the immune system to attack the body’s own tissues and organs.

Human Genome shares fell to $24.53 in after hours trading
from their Nasdaq close of $25.60.
(Reporting by Bill Berkrot, editing by Leslie Gevirtz)

UPDATE 2-FDA delays decision on Human Genome lupus drug