Lupus Drug At Pivotal Stage

Lupus Drug At Pivotal Stage [The News & Observer, Raleigh, N.C.]


From News & Observer (Raleigh, NC) (November 14, 2010)

 

Nov. 13--An experimental drug to treat lupus could clear an important regulatory hurdle next week.

The drug, known as Benlysta, would be the first new treatment for the autoimmune disease in more than 50 years. It also would provide a needed boost for its developers, Human Genome Sciences and GlaxoSmithKline.

A U.S. Food and Drug Administration panel is scheduled to recommend Tuesday whether Benlysta should be approved by the agency next month. The agency typically follows the recommendations of its panels, but not always.

Friday morning, in a preliminary review posted online, FDA staff raised some questions about Benlysta’s effectiveness in certain patients, including African-Americans. They also raised concerns that the drug’s benefits appeared to decrease over time.

"The robustness and the clinical meaning of the efficacy findings warrant discussion," the FDA staff wrote.

The panel could decide more clinical tests are needed or make another recommendation that could delay the drug. But analysts say the drug is likely to be approved and expect annual sales to exceed $2 billion eventually.

The unmet medical need will likely outweigh any concerns, Christopher Raymond, an analyst with Robert W. Baird in Chicago, told Bloomberg News.

"The drug has a relatively benign safety profile," and the panel’s review "ought to go smoothly," he said.

GSK officials would welcome positive news after a string of recent stumbles, including a $750 million settlement related to problems at a drug-manufacturing plant in Puerto Rico.

For Deirdre Connelly, the British company’s top executive at its North American headquarters in Research Triangle Park, winning approval of the drug would be an important professional victory, but also a personal one. Her father suffered from lupus for 16 years and died from it in 1994.

"Patients that suffered from that disease will have a solution; that’s very exciting to me," she said in a 2009 interview with The N&O, months after she was recruited to GSK after spending 25 years with drug maker Eli Lilly.

Connelly, through a GSK spokeswoman, declined further comment Friday.

GSK agreed in 2006 to work with Rockville, Md.-based Human Genome on its drug Benlysta, sharing development and marketing costs. The companies will split profits.

GSK has been handling some legal, regulatory and other support work for Benlysta out of RTP, where it employs nearly 5,000 people. The clinical work has been handled in Pennsylvania.

Human Genome’s shares have been climbing on expectations for the drug, and the stock will likely tumble if the FDA blocks or delays it.

On Friday, the stock fell 11 percent to $23.60 after the FDA posted its preliminary review. Shares of GSK, a much bigger company with a wide range of products, fell 13 cents to $39.62.

Lupus, which primarily strikes women of childbearing age, occurs when the body attacks itself, causing inflammation and tissue damage virtually anywhere in the body. The Lupus Foundation of America estimates 1.5 million Americans have the disease, although Human Genome and GSK initially plan to target about 200,000 patients with moderate or severe forms of the disease.

The foundation is one of several patient advocacy groups scheduled to testify at the panel meeting on Tuesday.

"It is a beacon of hope," foundation president Sandra Raymond told Dow Jones. "There hasn’t been, in the history of the disease, a drug aimed specifically at lupus."

Traditionally, lupus patients are treated with steroids or chemotherapy drugs that can have significant side effects.

In late-stage trials, Benlysta patients showed a greater response to the drug, compared with a placebo. The benefits continued in patients taking it for a year, but patients taking the drug for 76 weeks did not fare significantly better.

In August, the FDA granted the drug a prior review designation, a step the agency uses to accelerate its review of promising new treatments. The agency is expected to issue its decision Dec. 9.

Dow Jones Newswires and Bloomberg News contributed to this report.

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Posted: November 2010


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