FDA Concerns Over Human Genome Lupus Drug Dent Share Value

| About: GlaxoSmithKline (GSK)

Rheumatologists and other medical experts scheduled to convene November 16 to review Human Genome Sciences’ (HGSI) experimental lupus medicine will discuss safety and efficacy issues raised by a U.S. Food and Drug Administration briefing ahead of a vote on whether or not to recommend that the agency approve the drug.

Shares of Human Genome Sciences fell by 10 percent following the release of a document detailing concerns about the drug’s risks. Those risks include infection, malignancy, suicide, and death. But the drug is generally expected to achieve FDA approval.

FDA staff noted in a pre-review briefing that “various analyses of the data raise questions about the robustness of the efficacy findings,” and would warrant discussion at the meeting.

The review briefing’s authors express concerns about whether Benlysta improves the impact of lupus on important bodily organs, whether the drug is as effective for African Americans as it is for other racial groups, inconsistent efficacy trends across different geographical regions, the drug’s long-term effectiveness, and a possible exaggeration of the difference between placebo and Benlysta for the primary endpoint analysis.

An approval by the FDA would make Benlysta the first new lupus drug to be cleared by the agency in more than 50 years to fight the complex autoimmune disease. In August, the agency granted Benlysta, known known scientifically as belimumab, a priority review. It anticipates ruling on approval by of December 9.

Benlysta has shown promise in clinical studies, the cost of which Human Genome has shared with its partner GSK since the two companies struck a collaboration agreement in 2006. Global sales of the biotech drug are forecast to reach $2.2 billion by 2014, according to Thomson Reuters.

Lupus, a disease in which the immune system attacks healthy cells, appears most often in people between the ages of 10 and 50, according to the U.S. National Library of Medicine. African Americans and Asians are affected more often than people from other races.