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GSK sales slip, but profit climbs

GlaxoSmithKline, the Triangle's largest drug maker, reported stronger first-quarter profit, even as sales continued to slow.

The British pharmaceutical company saw a steep drop in sales of pandemic flu vaccines and its controversial diabetes drug Avandia. Sales declines in the United States and Europe were offset by gains in emerging markets and Asia.

The results met or exceeded most analysts' expectations. Most analysts expect GSK sales to rise in the second half of the year.

"GSK is making good progress against our strategic priorities and we had a very positive start to the year," CEO Andrew Witty said on a conference call. "We are continuing to see good underlying sales growth momentum."

FDA delays ruling on GSK lupus drug to March

Federal regulators, which were scheduled to issue a decision on a new drug to treat lupus next week, have delayed their decision until March.

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.

But that boost will be delayed, in a disappointment for the companies and investors.

The Food and Drug Administration has pushed back its review of the drug until March 10, the companies announced this afternoon. The FDA was scheduled to rule on Dec. 9, but requested more information on the drug.

FDA panel backs GSK's lupus drug

The first new treatment for lupus in more than 50 years won the blessing of a federal regulatory panel today, providing good news for patients and the drug's developers.

The U.S. Food and Drug Administration panel voted 13-2 that the drug, known as Benlysta, is safe and effective. Benlysta works well enough to outweigh risks of suicide, infection and cancer, and should be approved, the panel recommended.

The full FDA is scheduled to decide on the drug next month, and usually follows the recommendation of its advisory panels.

Analysts say the drug is likely to be approved because it addresses an unmet medical need, and some expect annual sales to exceed $2 billion eventually.

The drug to treat the incurable autoimmune disease would provide an important new revenue source for its developers, GlaxoSmithKline and Human Genome Sciences. 

GSK's lupus drug faces FDA panel next week

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.

This morning, in a preliminary review posted online, FDA staff raised some questions about Benlysta's effectiveness in certain patients, including African Americans. They also are worried that the drug's benefits appeared greater among patients in Latin America compared with those from the U.S. and Canada.

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

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

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