ROCKVILLE, Md. - Lupis is a painful disease that affects nearly five million Americans. No new treatments for it have been available for nearly 50 years, but that could soon change.

Janice Fitzgibbon was diagnosed with Lupus five years ago and has struggled with joint pain and chronic exhaustion.

She says about living with Lupus, "You just can't get through your day and when you have a flare, it's debilitating."

That struggle is why the busy mother of two teenagers was excited to hear about an apparent breakthrough in treating Lupus.

Rockville-based Human Genome Sciences has just successfully completed a second clinical trial of a new drug called Benlysta. Administered monthly using an IV drip, it effectively reduces a myriad of painful Lupus symptoms with no side effects. It's been a long time coming.

Human Genome Sciences CEO Tom Watkins says, "There's a realistic probability here that Benlysta would well be the first, new approved drug for Lupus in over 50 years and that's great news for these Lupus patients."

Up until now, Lupus patients have had very few options: a drug called Plaquinel, which some patients cannot tolerate, or steroids or aspirin.

Fitzgibbon, however, has been taking part in the clinical trials of Benlysta for more than a year and swears by it.

"I have been basically symptom-free," said Fitzgibbon. "It's a miracle!"

If the FDA approves Benlysta, it would be produced at a new manufacturing plant near HGS headquarters and marketed worldwide. 

Human Genome Sciences plans to file for FDA approval the first half of next year. If approved, Benlysta, which is administered monthly using an IV drip could hit the market by the end of 2010.

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