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