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GlaxoSmithKline Launches Phase 3 Trial for Benlysta

By Dan Carroll - Apr 4, 2013 at 7:24PM

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Study designed to test drug's effects on vasculitis patients.

Pharmaceutical maker GlaxoSmithKline (GSK 0.56%) will begin a phase 3 clinical trial to judge lupus medication Benlysta's effectiveness in treating patients with ANCA-positive vasculitis. The trial, which GlaxoSmithKline announced in a recent press release, will also evaluate Benlysta's safety profile; the drug has not been approved to treat vasculitis by any regulatory body, yet.

Benlysta was first approved by the FDA to treat adult patients with a specific type of lupus in 2011, and later that year added an approval from the European Commission. The drug recorded just over $100 million in sales last year, an underwhelming amount, considering the $3 billion GSK spent in 2012 purchasing its partner in developing Benlysta, Human Genome Sciences.

The company hopes success in treating vasculitis can fuel sales. The disease, which leads to the immune system's attacking of blood vessels, and can result in organ damage, affects between 102 to 284 people per million in the U.S., according to GSK's release.

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