Benlysta: Timeline of a lupus drug

After a five-decade drought, lupus patients have a new first-line treatment against the autoimmune disease: Human Genome Sciences' ($HGSI) Benlysta. The drug has blockbuster potential for the company, and its partner, GlaxoSmithKline ($GSK). Following the treatment's landmark approval, we're looking back at the ups and downs of Benlysta's R&D journey.

Date: March 9, 2011
Scoop: The FDA approves Benlysta, the first new lupus treatment in over 50 years. HGS has already amassed a 150-person sales force to start tracking down an estimated $3 billion in annual worldwide sales. HGS plans to conduct another trial to test the drug's efficacy on African-Americans, who make up one-third of lupus patients. Report

Date: Dec. 6, 2010
Scoop: Although HGS's drug had already made it through a panel gauntlet, the FDA postponed its planned Dec. 9 approval decision date until March, sending the company's shares briefly downward. Report

Date: Nov. 16, 2010
Scoop: With a 13 to 2 backing, an expert advisory panel recommended FDA approval for Benlysta, despite concerns over the drug's efficacy. Studies failed to support Benlysta's usage in African Americans, leading to tension from FDA experts and analysts. But lupus advocates still saw the drug's benefits. "I really do think the drug is efficacious," said Sandra Raymond, president & CEO of the Lupus Foundation of America. "What I'm hearing in terms of efficacy is pretty strong." Report

Date: June 10, 2010
Scoop: With its partner GlaxoSmithKline, HGS filed for Benlysta's FDA approval, thanks to positive results from two Phase III trials showing that the drug did lower disease activity and the frequency of lupus flareups in patients. Report

Date: April 20, 2010
Scoop: Although Benlysta did meet primary endpoints in its Phase III trial, the drug missed a secondary endpoint: it failed to show a statistically significant response after 76 weeks of therapy. According to the results, 38.5 percent of patients responded to a high dose of Benlysta for 76 weeks, compared to 32.4 percent on placebo. The lupus drug did, however, meet its key objective: a statistically significant response after one year. The results could impact the drug's overall sales, as doctors may prescribe shorter therapy time to maximize the drug's efficacy. Report

Date: Nov. 2, 2009
Scoop: HGS and GSK released a round of Phase III results showing a statistically significant response to high doses of Benlysta over placebo. In the BLISS-76 study, 43.2 percent response rate for patients on the therapy compared to 33.8 percent on placebo. And CEO Watkins also laid out the therapy's possible price: $20,000 per year. Report

Date: Oct. 20, 2009
Scoop: Benlysta supporters received good news with a round of Phase III results, as HGS reported that lupus flare-up frequency dropped by 24 percent, and severe flare-ups plummeted 43 percent on the drug, compared to placebo. "You can see the whole curve, and those benefits emerged at 16 weeks into treatment," Barry Labinger, HGS's chief commercial officer, told Bloomberg. "Getting a benefit over placebo so soon is impressive." Report

Date: July 20, 2009
Scoop: Thanks to unexpected positive trial results, HGS stock prices tripled. After disappointing early trial results, Benlysta proved skeptics wrong after the therapy reduced symptoms of the disease. But HGS execs knew the battle was just starting. "We have met the criteria in this study for success," said Thomas Watkins, Human Genome's president and chief executive. "Now we need to do it a second time in the other study." Report

Benlysta: Timeline of a lupus drug
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