GlaxoSmithKline (NYSE: GSK) and Human Genome Sciences (Nasdaq: HGSI) hope to secure approval from a Food and Drug Administration panel for their proposed drug that would treat lupus that could be a $1 billion blockbuster.
The Wall Street Journal reported Friday that the panel is to vote on Benlysta on Tuesday.
If the panel votes to support the drug, it could receive FDA approval as early as December, the Journal said.
Good news from the FDA would be a welcome break from recent news for the drug giant, which bases its U.S. headquarters in RTP and employs more than 4,000 people in the area.
GSK recently agreed to pay $750 million in a settlement with prosecutors in the U.S. for drug production problems in Puerto Rico. Sales of its diabetes drug Avandia have largely evaporated under increasing regulatory review and lawsuits.
And last week, Lauren Stevens of Durham, a former GSK attorney, was indicted in the U.S. obstructing justice and making false statements in an effort to conceal illegal promotion of the antidepressant drug Wellbutrin.
GSK was granted priority review for Benlysta by the FDA in August with a target action date of Dec. 9. Priority review designations are for drugs that could provide major advances in treatment of a disease where a current therapy doesn’t exist.
The Lupus Foundation defines lupus as “a chronic, autoimmune disease that can damage any part of the body.”
Priority review designations are for drugs that could provide major advances in treatment of a disease where a current therapy doesn’t exist.
According to the Lupus Foundation, the disease affects some 1.5 million people in the U.S. and 5 million worldwide.
Lupus strikes mostly women of childbearing age, the Foundation says.
GSK and Human Genome Sciences submitted results from two Phase III clinical trials.
“Belimumab is the first medicine for lupus that has completed Phase III trials with positive results,” said Carlo Russo, GSK’s senior vice president of Biopharm Development, in August.
“We look forward to continuing to work together with HGS to progress regulatory files and we hope that we will be able to deliver a new treatment option for patients living with lupus,” he added.
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