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Phase III success for GSK's lupus drug

Published on 03/11/09 at 12:17pm


GlaxoSmithKline's lupus drug Benlysta has been successful in the second of two phase III trials, following earlier performance that exceeded market expectations.

The first in a new class called BLyS-specific inhibitors, Benlysta (belimumab) is aimed at patients with systemic lupus erythematosus (SLE), a chronic, life-threatening autoimmune disease.

The investigational monoclonal antibody is being developed by GlaxoSmithKline and Human Genome Sciences (HGS) as part of a deal signed in 2006.

Benlysta met its primary endpoint in BLISS-76 on seropositive patients with SLE when a 10 mg/kg dose plus standard of care achieved a "statistically significant improvement" over 52 weeks in patient response compared with placebo plus standard of care.

"Benlysta has the potential to become the first new approved drug in decades for people living with systemic lupus," said HGS chief executive H. Thomas Watkins.

The drug was generally well tolerated and the companies plan to submit marketing applications in the US and Europe in the first half of next year.

Carlo Russo, GSK's senior vice president of biopharm development, said: "The results from this second pivotal phase III trial reinforce our belief that belimumab could deliver a significant therapeutic option for patients."

In July the drug surprised analysts in the first of these trials when it also offered significant improvement in symptoms in SLE patients compared to placebo.

It has been more than 50 years since the last new drug for lupus was approved and an earlier Benlysta trial had been disappointing.

There is also a low success rate in the therapy area - Biogen Idec and Roche's Rituxan was a recent late-stage failure.

BLISS-76 will continue for 24 more weeks and more data will be available at the end of its full 76-week study period.

SLE is one of a number of forms of lupus, a disease which affects around five million people worldwide.

Around 90% of lupus patients are female, especially between the ages of 15 and 45, and particularly in black, Asian and Hispanic populations.

Fatigue, painful and swollen joints, fever, skin rash and kidney problems are the major symptoms.

GSK files retigabine in US and Europe

Meanwhile, GSK has filed a New Drug Application with the US FDA and a Marketing Authorisation Application with the EMEA for retigabine, used as adjunctive therapy to treat adult epilepsy patients with partial-onset seizures.

The drug, which GSK is developing with Valeant Pharmaceuticals International is not approved or licensed anywhere in the world.

During the summer, it failed to meet its goal in a mid-stage clinical trial for post-shingles pain.

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