NEWS - Benlysta (belimumab) for lupus likely to be approved Thursday

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Benlysta For Lupus Likely To Be Approved This Thursday, A Potential Blockbuster

MedicalNewsToday.com

Article Date: 07 Mar 2011 - 14:00 PST

Benlysta (belimumab) is expected to gain US approval this week by the

Food and Drug Administration (FDA), USA, for the treatment of lupus

(systemic lupus erythematosus). This is the first drug approval with

benefits for lupus patients in half-a-century. Pharmaceutical experts

believe Benlysta will become a huge blockbuster, with potentially $3

billion plus global annual sales within the next four years. They also

add that approval is highly likely this coming Thursday.

Human Genome Sciences, the makers of Benlysta, is currently a biotech

company running at a loss. Benlysta's approval will change everything,

and most likely it will become ripe for takeovers overnight. The new

medication's long-term sales estimates are high, with possibly annual

sales of over $5 billion by 2019 (Wall Street Journal).

Early on, Human Genome Sciences' future looked bleak when initial

trial data disappointed. However, during the Spring of 2009 things

started to look more encouraging. The company's future took a massive

turn for the better when an FDA Advisory Panel recommended approval in

a 13-2 vote in November 2010.

There is still some concern over whether regulatory authorities might

insist on some limits when the drug is approved. Experts say it does

not help all lupus patients, while others have described its benefits

as " mild " . Most expect the approval to cover a fairly broad population

with moderate to severe lupus symptoms.

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http://www.medicalnewstoday.com/articles/218427.php

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