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Lupus Drug Benlysta by Human Genome Sciences and GlaxoSmithKline looks promising
By Elizabeth Haggar for CEOWORLD Magazine Updated:November 2, 2009
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Human Genome Sciences (NASDAQ:HGSI) and GlaxoSmithKline PLC (NYSE:GSK) announced Monday morning that BENLYSTA met the primary endpoint in the second of two Phase 3 trials in seropositive patients with systemic lupus erythematosus.
Companies hope will be the first treatment to receive approval for lupus in over 50 years.
The drug works by suppressing the immune system’s response to lupus, and if approved would be the leading drug on the market to treat the condition.
The drug was compared to placebo, in a trial of patients living with lupus, and proved without any doubt to be effective at reducing symptoms associated with the disease.
The results from the most recent clinical study were not as persuasive as those from the first study, however still looked strong enough to get the go-ahead from regulators and ensure doctors use the drug widely, industry analysts said on Monday. The companies need to give two positive clinical trials of a lupus drug for approval, so investors have waited nervously for Monday’s findings from the so-called Bliss-76 study of Benlysta ever since the positive data from the first study, Bliss-52, were released in July
The new study showed patients given a high dose of Benlysta had a statistically significant improvement in symptoms compared with patients who were given the placebo.
“The results from this second pivotal Phase 3 trial reinforce our belief that belimumab could deliver a significant therapeutic option for patients with lupus who have had no new treatment in 50 years. We look forward to continuing our collaboration with HGS in order to bring this important medicine to patients,” Carlo Russo, GlaxoSmithKline’s Senior Vice President, Biopharm Development, said.
Currently there is no cure for lupus, which triggers the immune system to attack healthy cells and affects approximately 5 million people around the world. London-based Glaxo and Human Genome Sciences, based in Rockville, Maryland, hope to sell the drug in the U.S., Europe and other countries in the first half of 2010, Human Genome Sciences Chief Executive Officer Thomas Watkins said in the statement.
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