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New Lupus Drug Facing Hard Questions

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FDA scientists question the effectiveness and safety of new lupus drug Benlysta, yet analysts see nothing blocking or delaying approval.

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Human Genome Sciences (HGSI) faces some very tough questions next week as it makes its case for selling the first new lupus drug (Benlysta) in half a century. But there doesn't appear to be anything in the US Food and Drug Administration briefing that's going to definitely sink Benlysta's chances or delay approval.

Human Genome and partner GlaxoSmithKline (GSK) will face a panel of FDA expert advisers who will weigh the benefits of the drug Tuesday. As is customary, FDA scientists prepared a report outlining what they see as the potential risks and rewards of the new drug, a would-be blockbuster product for the two companies. FDA staff focus their attention -- as is the case with any new drug approval -- on whether the medicine works, and its safety. FDA scientists, in a document [pdf] posted on the agency's website this morning, raised concerns about deaths in the company's own studies. You can view the full list of questions for the panel here [pdf}.
"The apparent increased mortality risk with (Benlysta) remains concerning, particularly in light of the marginal efficacy observed," agency staffers say in their report.

The risks, according to the report, include "infection, malignancy, suicidality, and overall number of deaths." There were 15 deaths in a study of more than 2,000 people -- 12 patients taking two different doses of Benlysta and three who received placebos.

The companies are also going to need to answer questions about the effectiveness of the drug in African-Americans (it doesn't appear to work) and three suicides among study participants.

The consensus among Wall Street analysts (who aren't always right about these drug approvals) is that Benlysta will sail through the approval process.

"There is nothing noted that we would not expect to be a fair topic of discussion for a groundbreaking new drug in an extremely difficult disease state," says Leerink Swann analyst Joseph Schwartz, who rates the stock a buy. "We believe FDA briefing documents released today remove an overhang that unknown issues could present as obstacles to approval of Benlysta."

Some investors aren't waiting around to see the results. Shares dropped 8% to $24.28 in midday trading Friday. The stock fell 14% in the past month.

Some analysts are reaching out to the medical community, surveying doctors who would prescribe the product. Their take: Benlysta is safe and even if the FDA deems the drug only "moderate" in its effectiveness, the demand for a new lupus drug is high.

"Experts we spoke with commented it is 'quite safe,'" says RBC Capital Markets analyst Michael Yee, who rates the stock a buy. "We believe moderate efficacy is not likely to significantly limit uptake in lupus, which is a high unmet serious disease. Docs suggested they expect to use the drug although more data would be helpful in understanding how 'long' to use the drug."


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