Benlysta works by targeting a protein called BLISS that came out of HGS' gene databases.
In smaller studies, Benlysta had failed to provide a benefit across all patients with lupus.
Those receiving Benlysta during clinical studies reported more deaths and serious infections compared with placebo.
FORBES: Human Genome Sciences' Benlysta Approved To Treat Lupus
Two clinical studies involving 1, 684 patients with lupus demonstrated the safety and effectiveness of Benlysta.
FORBES: Human Genome Sciences' Benlysta Approved To Treat Lupus
Prior to Benlysta, FDA last approved drugs to treat lupus, Plaquenil (hydroxychloroquine) and corticosteroids, in 1955.
FORBES: Human Genome Sciences' Benlysta Approved To Treat Lupus
The manufacturer is required to provide a Medication Guide to inform patients of the risks associated with Benlysta.
FORBES: Human Genome Sciences' Benlysta Approved To Treat Lupus
Glaxo's first big success may come early next year, if its new lupus drug, Benlysta, is approved by regulators.
GlaxoSmithKline ( GSK - news - people ) will help market Benlysta and receive half the sales.
The Benlysta results will still need to be released and scrutinized at a major medical meeting or in a medical journal.
African American patients and patients of African heritage participating in the two studies did not appear to respond to treatment with Benlysta.
FORBES: Human Genome Sciences' Benlysta Approved To Treat Lupus
Patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard of care medicines.
FORBES: Human Genome Sciences' Benlysta Approved To Treat Lupus
But pretty much all the gain is due to the success in large trials last year with its new lupus drug Benlysta.
Lupus can lie dormant for long periods of time--the idea was that Benlysta only works if the immune system is actively attacking the body.
Zymogenetics and Merck-Serono had stopped one study of a lupus treatment that was in some ways similar to Benlysta because of an infection risk.
The studies diagnosed patients with active lupus and randomized them to receive Benlysta plus standard therapy, or an inactive infused solution (placebo) plus standard therapy.
FORBES: Human Genome Sciences' Benlysta Approved To Treat Lupus
Wall Street had every reason to be skeptical about Benlysta.
Benlysta will be co-marketed by Human Genome and GlaxoSmithkline.
FORBES: Human Genome Sciences' Benlysta Approved To Treat Lupus
To address this concern, the sponsor has agreed to conduct an additional study of people with those backgrounds to further evaluate the safety and effectiveness of Benlysta for this subgroup of lupus patients.
FORBES: Human Genome Sciences' Benlysta Approved To Treat Lupus
So far, side effects from Benlysta have been mild, but the drug works by dulling the immune system, so doctors and investors will be watching closely to see if it raises the risk of infection.
Benlysta is delivered directly into a vein (intravenous infusion) and is the first inhibitor designed to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells thought to be a problem in lupus.
FORBES: Human Genome Sciences' Benlysta Approved To Treat Lupus
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