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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

US Clears GlaxoSmithKline, Vertex AIDS Drug


Reuters (10.20.03) - Tuesday, October 21, 2003

On Monday, the US Food and Drug Administration approved a new protease inhibitor developed by GlaxoSmithKline Plc and Vertex Pharmaceuticals Inc. The drug, previously known as 908, will be sold under the brand name Lexiva. FDA approved Lexiva for use with other HIV-suppressing medications.

Dr. Debra Birnkrant, director of FDA's division of antiviral products, said Lexiva offers patients a new option that allows them to reduce the number of pills they must take daily. Dosing options include taking two pills twice daily, or taking one pill twice daily with ritonavir, Birnkrant said, noting that other medicines can require as many as eight pills twice daily. "Pill burden-wise, [Lexiva] is somewhat of an improvement, she said.

The new drug's dosing flexibility offers "a huge advantage to patients and doctors," said Vertex CEO Joshua Boger. He said Lexiva is less likely to cause diarrhea than Pfizer Inc.'s protease inhibitor Viracept.

Chemically, Lexiva is similar to Vertex's HIV drug Agenerase, which had 2002 sales of about $65 million. Vertex expects Lexiva to take over much of the Agenerase market and to take market share from Viracept and Abbott Laboratories Inc.'s Kaletra.


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Information in this article was accurate in October 21, 2003. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.