AN ADVISORY panel for the US Food and Drug Administration (FDA) last night recommended that the agency approve a new treatment for lupus developed by GlaxoSmithKline (Glaxo) with peer Human Genome Sciences.
The committee voted 13-2 in favor of a drug called Benlysta – which analysts estimate could see annual global sales of $2.2bn by 2014 and exceed $5bn by 2020.
Profits from the drug would be split equally between currently unprofitable biotech firm Human Genome and Glaxo.
The FDA, which should make a decision by early December, isn’t required to follow the advice of its panels, but usually does.
Benlysta is important for both companies as it’s one of the most important new drugs in Glaxo’s pipeline and Human Genome has no products on the market.
The drug’s success in two large studies has produced consistent speculation that Glaxo would acquire Human Genome.
There have been no new treatments in the last few decades for lupus, a disease in which the body’s immune system attacks its own organs and tissues and is most often seen in women of child-bearing age.
Symptoms can include fever, swollen joints, skin rashes and severe damage of the kidneys, lungs or central nervous system. US-listed Glaxo’s shares gained 3.4 per cent to $39.85 in after-hours US trading.