FDA hands GSK, Human Genome Sciences landmark Benlysta approval

The FDA has delivered a widely anticipated approval for the lupus drug Benlysta, unleashing a small army of reps as Human Genome Sciences ($HGSI) and GlaxoSmithKline ($GSK) set out to try and deliver on peak annual sales estimates of more than $3 billion a year worldwide. Bloomberg reports that HGS commercial chief Barry Labinger told reporters that the therapy, the first new drug for lupus in more than half a century, will be sold for $35,000 a year.

There's been only a modest upswing in HGSI stock in premarket trading, not unusual given near unanimity among analysts that the developer had a near lock on an approval. The drug delivered on its primary endpoint of demonstrating a reduction in overall disease activity, a tricky proposition for a disease that afflicts patients in different ways.

For Human Genome Sciences, which has already recruited a sales force of 150, the approval marks a landmark shift toward commercial operations after years of discovery and development work. For GSK it's a key mega-blockbuster approval that can deliver a major stream of cash for years to come. And for analysts and reporters, it's a fresh opportunity to warm up old rumors of a potential takeover of HGS.

The development team still has some work to do, though. Regulators said that the data indicated that blacks didn't respond to the drug, but didn't feel there were enough black patients in the trial to provide definitive proof one way or the other. Investigators will now undertake a new trial of African-American patients as a condition of the approval. About a third of all lupus patients are black, but regulators have placed no limitations on the use of the drug. And the two companies aren't about to rest on any laurels now.

"We expect to have this novel therapy available to physicians and patients within about two weeks," said HGS CEO Tom Watkins, "and our entire organization looks forward to the positive impact we hope this new therapy will have for patients with systemic lupus."

- see the HGSI release
- check out the story from Bloomberg
- and here's the Dow Jones report