LG's pneumonia drug on track

GAITHERSBURG, United States (Reuters) -- U.S. advisers have backed a new antibiotic developed by South Korea's LG Life Sciences called Factive for treating a common type of pneumonia and flare-ups of chronic bacterial bronchitis.

The recommendation now goes to the Food and Drug Administration, which usually follows its panels' advice.

LG Life Sciences has licensed North American and European rights to privately-held GeneSoft Pharmaceuticals Inc.

The FDA advisory panel voted 18-0, with one abstention, for approval for the community-acquired pneumonia indication, and 15-3, with one abstention, for approval for the bronchitis indication.

Community-acquired pneumonia is defined as pneumonia acquired outside a hospital or nursing home setting.

Earlier rejection

The companies also sought approval for the indication for pneumonia resistant to current antibiotics. Panelists did not vote formally on that request, but a majority said Factive should get that claim.

"I think it's very important to get this drug on the market," said panelist and Annandale, Virginia-based infectious disease specialist Donald Poretz, citing the need for more antibiotics that can defeat drug-resistant bacterial strains.

The panel was presented data showing that Factive cured pneumonia in 89 percent of patients who took the drug for a week. Factive cured bronchitis flare-ups in 88-93 percent of those who took a five-day course.

The FDA had rejected Factive in December 2000, citing concerns about efficacy and about potential liver damage and drug-related rashes.

Glaxosmithkline Plc submitted that application and later abandoned Factive development.

Story Tools		Subscribe to Time for $1.99

Nikkei rebounds to above 10,000 • Japan talks trade at ASEAN summit • Japan-Thailand move on trade talks • China, U.S. lead oil demand boom

CNN/Money: Security alert issued for 40 million credit cards • Bin Laden deputy sends message • U.S. House votes to keep U.N. dues • Iran poll to go to run-off