FDA Approves Human Genome (HGSI), Glaxo Drug Benlysta

VFC submits: The long wait is over for Human Genome Sciences (HGSI), partner GlaxoSmithKline (GSK) and investors of both companies as the FDA announced on Wednesday that Benlysta has been granted approval for the treatment of lupus.

Pharmalot submits: Every so often, a new approval generates significant attention. And the FDA endorsement of Benlysta, the first new treatment for lupus in 56 years, is one of those moments.

The Burrill Report submits: By Michael Fitzhugh

Pharmalot submits: On Tuesday, an FDA advisory panel will review the first new treatment for lupus in decades. And the early indications are that Benlysta, which is being developed by Human Genome Sciences (HGSI), will win an endorsement. At least that’s how some Wall Street analysts are interpreting the FDA briefing documents filed Friday morning, even though the stock is trading down.

Todd Johnson submits:Human Genome Sciences (HGSI) is finally coming to market with the full FDA approved medication. The company's early years hype, and later years near-death stock experience, can all be viewed in perspective.

Ketan Desai submits:The FDA is expected to rule on Benlysta this week. If the FDA approves Benlysta as per the recommendation of the advisory board, it will be the first new drug to treat systemic lupus erythematosus in half a century. And sales will be at least in the billion dollar range, if not more. Approval will lead the stock to skyrocket, and the company may even be bought out. However, the FDA is known to be unpredictable, not always following the advice of its advisory board.

By VFC: The good news didn't last long for Human Genome Sciences (HGSI).